|
|---|
| Douglas Laboratories |
Immunity |
202018-120HYC-C |
No change |
Reformulation: Revise Medicinal Ingredients to update source of Vitamin C. Product label formatting update - Andrographis Leaf Extract, ratio for Elderberry Fruit Extract and added potency for Garlic Bulb Extract. Revise Recommended Use to comply with Health Canada Elderberry monograph.
- Change source of Vitamin C FROM calcium ascorbate TO ascorbic acid, calcium ascorbate, magnesium ascorbate
- Change Andrographis Leaf Extract FROM (12.8 mg andrographolide) TO (10% andrographolide)
- Change Elderberry Fruit Extract ratio From (35:1; 3631 mg dried equivalent; 6.2 mg anthocyanosides) To (75-85:1) (7.8 g-8.8 g dried equivalent, 6% anthocyanosides)
- Change Garlic Bulb Extract FROM (20:1) (262.6 mg dried equivalent, 0.13 mg allicin) TO (1% allicin; 2.2% alliin)
- Revised Recommended Use FROM “Adults Take 2 capsules 2 times daily” TO “Adults Take 2 capsules daily”
Address updated to 1-150 Via Renzo Drive, Richmond Hill, ON L4S 0J7
New label V3
|
10/08/2021 |
11/01/2021 |
|
|---|
| Douglas Laboratories |
Klean Probiotic |
KA200900-60HYC-C |
|
Reformulation: Revise capsule, add probiotic stabilizing ingredients as non-medicinal ingredients per Health Canada monograph, revise FOS label claim and risk information to align with new product license.
Update NPN, UPC, Product Code, address, NSF logo.
Changes to medicinal ingredients:
- Change Fructooligosaccharides (FOS) Label Claim From 165 mg To 160 mg
Changes to non-medicinal ingredients:
- Remove Bovine gelatin (capsule), magnesium stearate, silica
- Add “Capsule (hypromellose, pectin, glycerol, purified water), cellulose. Ingredients used to maintain viability of probiotics (dipotassium phosphate, monopotassium phosphate, trehalose, dextrose, sucrose, sodium chloride, sodium ascorbate, acacia gum).”
Change Capsule from a gelatin capsule to a vegetarian acid-resistant capsule.
Changes to Risk Information:
- Add Do not use if “you are taking tetracycline, clindamycin or kanamycin.”
New Item # KA202516-60HYC-C
New UPC: 3 10539 97886 3
New NPN: 80096622
New NSF Logo
Address updated to Richmond Hill, ON L4S OJ7
New label V1
|
08/24/2021 |
08/30/2021 |
|
|---|
| Douglas Laboratories |
Ultra Protein Plus (Natural Vanilla Bean Flavour) |
57054-908HYC-C |
|
Reformulation: Revise Medicinal Ingredient panel and Non-Medicinal Ingredients, Revise source of Vitamin E / Folate / Vitamin B12 / Choline/ Magnesium / Manganese / Potassium / Boron, Remove L-Glutamic acid & LMethionine, Revise Suggested Usage, Decrease net weight per bottle from 908g to 900g, Decrease serving size from 30.2g to 30g, Decrease bottle size, Add soy allergen disclaimer, Remove milk allergen from label.
Update NPN, UPC, Product Code.
- Change Vitamin A label claim FROM 726.8 mcg RAE (2405 IU) TO 357 mcg RAE
- Change Beta-carotene label claim FROM 2220 mcg (3700 IU) TO 1016 mcg
- Change Vitamin D label claim FROM 0.625 mcg (25 IU) TO 10 mcg
- Change Vitamin E label claim FROM 67 mg AT TO 33.5 mg AT
- Change Pea Protein label claim FROM 16 g TO 19.6 g
- Change Thiamine label claim FROM 23 mg TO 24 mg
- Change Vitamin B6 label claim FROM 22 mg TO 24 mg
- Change Vitamin B12 label claim FROM 25 mcg TO 50 mcg
- Change Pantothenic Acid label claim FROM 125 mg TO 50 mg
- Change Calcium label claim FROM 112 mg TO 115 mg
- Change Iodine (kelp) FROM 45 mcg TO Japanese Kelp Whole…13.25 mg / Providing: 50 mcg Iodine
- Change Choline label claim FROM 34 mg TO 20 mg
- Change Manganese label claim FROM 4.5 mg TO 2.5 mg
- Change Potassium label claim FROM 22 mg TO 20 mg
- Change N-Acetyl-L-Cysteine label claim FROM 11 mg TO 10 mg
- Change Betaine label claim FROM 34 mg TO 25 mg
- Change Vanadium label claim FROM 11 mcg TO 12 mcg
- Change Vitamin E source FROM d-alpha tocopheryl acetate TO d-alpha tocopheryl acid succinate
- Update source of Folate to calcium L-5-methyltetrahydrofolate, Metafolin®/MD
- Change source of Vitamin B12 FROM cyanocobalamin TO methylcobalamin
- Change source of Choline FROM choline bitartrate, choline dihydrogen citrate TO choline bitartrate
- Change source of Magnesium FROM magnesium aspartate, magnesium ascorbate, magnesium oxide TO magnesium oxide, citrate, ascorbate
- Change Manganese source FROM manganese sulfate, manganese aspartate TO manganese sulfate
- Change source of Potassium FROM potassium aspartate, potassium chloride TO potassium chloride
- Change source of Boron FROM boron aspartate, boron citrate TO boron citrate
- Remove L-Glutamic Acid…4.1 mg
- Remove L-Methionine…2 mg
- Change Non-Medicinal Ingredients FROM “D-fructose, vanilla flavour, maltodextrin, oligofructose (BeFlora™), cellulose, magnesium stearate, silica, stearic acid.” TO “Organic cane sugar, organic vanilla flavour with other natural flavours, organic tapioca maltodextrin, rebaudioside A (stevia extract),
monk fruit extract.”
- Revise Suggested Usage to include “Take once daily with a meal”
- Revise Risk Information: Do not use if you are taking antibiotics or nitroglycerin.
Consult your healthcare practitioner prior to use if you are pregnant or breastfeeding, are taking sulfonamides or blood thinners, or have kidney stones, a peptic ulcer or excess stomach acid. Stop use if allergy occurs. People sensitive to nicotinic acid may experience flushing of the skin that is generally
mild and transient.
- Add disclaimer: May contain trace amounts of soy due to agricultural practices.
- Decrease Bottle Size FROM 2500cc TO 1060cc white HDPE canister
New Product Code# 57395-900HYC-C
New UPC: 3 10539 97882 5
New NPN: 80091574
New label V2
|
06/14/2021 |
06/25/2021 |
|
|---|
| Douglas Laboratories |
DIM Enhanced |
202364-30HYC-C |
|
Reformulation: Replace Meriva® derived from soy to Meriva® derived from sunflower, revise Non-Medicinal Ingredients, remove soy allergen, update product code & UPC.
Change to Non-Medicinal Ingredients:
- Change phosphatidylcholine FROM (from sunflower and soy) TO (from sunflower)
New Item # 202558-30HYC-C
New UPC 3 10539 97953 2
Address updated to Richmond Hill, ON L4S OJ7
New Label V2
|
05/14/2021 |
05/13/2021 |
|
|---|
| Douglas Laboratories |
Magnesium Glycinate |
202559-120HYC-C |
No change |
Revise Non-medicinal ingredients
- Change tablet coating FROM (polyvinyl alcohol, polyethylene glycol, polysorbate 80, talc) TO (hypromellose, glycerin)
- New label V2
|
05/5/2021 |
05/13/2021 |
|
|---|
| Douglas Laboratories |
Betaine Plus |
80106-250HYC-C |
No change |
Reduce capsule size. Revise packaging, suggested usage, and PDP to align with monographs.
- Decrease capsule size FROM size "00 Elongated" (25.3mm x 8.53mm) TO size "00" (23.30mm length x 8.53mm diameter)
- Bottle size decrease FROM 625cc to 500cc white HDPE bottle
- Change Suggested Usage statement FROM “Adults: Take 1 capsule with each meal (3 capsules daily) or as directed by your healthcare practitioner.” TO “Adults: Take 1 capsule daily with a meal or as directed by your healthcare practitioner.”
- Remove “liver function” health claim from PDP
- New Label V3
|
05/5/2021 |
05/13/2021 |
|
|---|
| Douglas Laboratories |
Brain Calm |
99579-60HYC-C |
No change |
Revise packaging, increase capsule size
- Increase capsule size FROM size "00" (23.30mm length x 8.53mm diameter) TO size "00 Elongated" (25.3mm x 8.53mm)
- Bottle size increase FROM 150cc TO 180cc white HDPE bottle
- Address updated to 1-150 Via Renzo Dr., Richmond Hill, ON L4S OJ7
- New label V3
|
05/4/2021 |
05/13/2021 |
|
|---|
| Douglas Laboratories |
Calcium Microcrystalline Hydroxyapatite |
83018-90HYC-C |
No change |
Revise Non-medicinal ingredients
- Change tablet coating FROM (polyvinyl alcohol, talc, polyethylene glycol, polysorbate 80) TO (hypromellose, glycerin)
- New label V3
|
04/21/2021 |
05/13/2021 |
|
|---|
| Douglas Laboratories |
Opti-EPA |
99276-60HYC-C |
No change |
Revise Fish Oil, revise Non-medicinal ingredients, update NPN
- Change Fish Oil source and label claim FROM anchovy and mackerel…900 mg TO anchovy…850 mg
- Remove ascorbyl palmitate, mixed tocopherols, coconut oil, ammonium hydroxide
- Add medium chain triglycerides, oleic acid
- Address updated to 1-150 Via Renzo Dr., Richmond Hill, ON L4S OJ7
- New NPN 80094253
- New label V4
|
04/09/2021 |
05/13/2021 |
|
|---|
| Douglas Laboratories |
Magnesium Glycinate |
202559-120HYC-C |
No change |
Revise Non-medicinal ingredients
- Change tablet coating FROM (polyvinyl alcohol, polyethylene glycol, polysorbate 80, talc) TO (hypromellose, glycerin)
- New label V2
|
05/5/2021 |
05/13/2021 |
|
|---|
| Douglas Laboratories |
Joint Tendon Ligament I |
201691-90HYC-C |
No change |
Revise Spinach extract to Spinach powder
- Address updated to Richmond Hill, ON L4S OJ7
New label V5
|
3/29/2021 |
04/07/2021 |
|
|---|
| Klean Athlete |
Klean Multivitamin |
KA201344-60HYC-C |
No change |
Revise Spinach extract to Spinach powder
- Address updated to Richmond Hill, ON L4S OJ7
New label V4
|
3/29/2021 |
04/07/2021 |
|
|---|
| Douglas Laboratories |
Chelated-C Plus |
7847-100HYC-C |
|
Reformulation: Update source of Vitamin C, revise Non-medicinal ingredients, update capsule.
Update Brand name, product code, UPC, & address.
- Change source of Vitamin C FROM calcium ascorbate (Ester-C®) TO calcium ascorbate / ascorbyl palmitate
- Remove gelatin (capsule), magnesium stearate
- Add Hypromellose (capsule)
- Change capsule FROM Gelatin “00” TO Vegetarian “00” (23.30mm length x 8.53mm diameter)
- Change Brand name FROM Ester-C® Plus TO Chelated-C Plus
- New Item # 202639-100HYC-C
- New UPC: 3 10539 97955 6
- Address change to 1-150 Via Renzo Dr., Richmond Hill, ON L4S OJ7
- New label 202639-100HYC V2
|
3/11/2021 |
04/07/2021 |
|
|---|
| Douglas Laboratories |
Choles-Sterol |
99134-120HYC-C |
No change |
Revise medicinal ingredient Sytrinol potencies to list quantities in mg
- Change Citrus Bioflavonoids FROM 30% TO 22.5 mg
- Change Tocotrienols FROM 1.5% TO 1.125 mg
- New label V4
|
3/05/2021 |
04/07/2021 |
|
|---|
| Douglas Laboratories |
Spectramin Chelate |
Spectramin Chelate |
No change |
RRevise Non-medicinal ingredients
- Change tablet coating FROM (polyvinyl alcohol, talc, polyethylene glycol, polysorbate 80) TO (hypromellose, glycerin)
- New label V4
|
3/05/2021 |
04/07/2021 |
|
|---|
| Klean Athlete |
Klean Endurance |
Klean Endurance |
|
Update product code & UPC, replace Non-medicinal ingredient natural vanilla flavour & remove milk allergen, update NSF logo
- New Item# KA202598-90HYC-C
- New UPC: 3 10539 97919 8
- New label V1
|
3/05/2021 |
04/07/2021 |
|
|---|
| Douglas Laboratories |
Betaine Plus |
80106-250HYC-C |
No change |
Reformulation: Revise excipients/Non-medicinal ingredients to add silica. Reduce overage to fit into size “00” capsule. Revise packaging, suggested usage, and PDP to align with monographs.
- Add silica
- Decrease capsule size FROM size "00 Elongated" (25.3mm x 8.53mm) TO size "00" (23.30mm length x 8.53mm diameter)
- Bottle size decrease FROM 625cc to 500cc white HDPE bottle
- Change Suggested Usage statement FROM “Adults: Take 1 capsule with each meal (3 capsules daily) or as directed by your healthcare practitioner.” TO “Adults: Take 1 capsule daily with a meal or as directed by your healthcare practitioner.”
- Remove “liver function” health claim from PDP
- New Label V3
|
02/15/2021 |
02/25/2021 |
|
|---|
| Klean Athlete |
Klean Focus |
KA201308-90HYC-C |
No change |
Update Label to align with new product license.
- Change Acetylcarnitine label claim FROM 282 mg TO 283 mg
- Change Suggested Usage statement FROM “Adults: Take 1 capsule 3 times daily or as directed by your healthcare practitioner.” TO “Adults: Take 3 capsules daily with meals or as directed by your healthcare practitioner.”
- Revise excipients / Non-medicinal ingredients to remove Latin from fruit names
- Remove “cognitive function” health claim from PDP
- Add Soy allergen statement
- New NPN 80104496
- Update to NSF logo
- New Label V4
|
02/9/2021 |
02/25/2021 |
|
|---|
| Douglas Laboratories |
Zinc Lozenges |
ZNL-HYC-C |
202648-100HYC-C |
Reformulation: Revise Active/Medicinal ingredients to add Vitamin C. Revise excipients/Non-medicinal ingredients to remove magnesium stearate. Update suggested use, product code, UPC, and NPN.
- Remove magnesium stearate, sorbitol, stearic acid
- Add xylitol, mannitol, hyprolose
- Change Suggested Use FROM “Children (6-8 years): Take 1 lozenge once daily. Adolescents (9-13 years): Take 1 lozenge 1-2 times daily. Adolescents (14-18 years): Take 1 lozenge 1-3 times daily. Adults: Take 1 lozenge 1-5 times daily. Take with food, a few hours before or after taking other medications or natural health products, or as directed by your healthcare practitioner. Allow to dissolve completely in the mouth.” TO “Adults, take 1 lozenge 1-3 times daily; adolescents and children (6 years and older), take 1 lozenge once daily, or as directed by your healthcare practitioner. Take with meals, a few hours before or after taking other medications or natural health products. Allow lozenge to dissolve in mouth or chew and then swallow.”
- New Item# 202648-100HYC-C
- New UPC: 3 10539 97956 3
- New NPN 80104789
- New Label V2
|
01/27/2021 |
02/25/2021 |
|
|---|
| Douglas Laboratories |
Vitamin K2 |
200913-60HYC-C |
|
Reformulation: Revise excipients / Non-Medicinal Ingredients to remove magnesium stearate. Update product code, UPC, RHDC address & label PDP.
- Remove magnesium stearate, silica, calcium citrate
- Add ascorbyl palmitate
- New Item# 202597-60HYC-C
- New UPC: 3 10539 97954 9
- New Label V1
- Change RHDC address from Richmond Hill, ON L4C 0L8 to Richmond Hill, ON L4S 0B4
- Change PDP From Soy free & “Helps in the maintenance of bones.” To “Helps in the maintenance of bones. Helps to prevent vitamin K deficiency.”
|
11/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ultra Balance III Capsules |
200585-180HYC-C |
No change |
Reformulation: revise excipients, update NPN
- Add sea salt
- New NPN 80081043
Label updated from V1 to V2
|
10/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Chromium 200 mcg |
200063-100HYC-C |
No change |
Update to Brand Name, Direction of Use, Supplier trademark and logo and Address
- Change brand name from Chromium-GTF to Chromium 200 mcg
- Change suggested usage From “Adults: Take 1 capsule daily with a meal or as directed by your healthcare practitioner.” To “Adults: Take 1 capsule daily or as directed by your healthcare practitioner.”
- Change trademark "ChromeMate® is a registered trademark of InterHealth Company N.I." to "ChromeMate® is a Lonza trademark, registered in USA".
- Change RHDC address from Richmond Hill, ON L4C 0L8 to Richmond Hill, ON L4S 0B4
|
10/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Citrus-Q10 100 |
200053-60HYC-C |
No change |
Reformulation: Revise excipients / Non-Medicinal Ingredients to remove sorbitol, add ascorbyl palmitate & update order. Update to recommended use, suggested usage, Tablet, Bottle & Label Size.
- Change recommended use from “Helps to maintain and support cardiovascular health.” To “Helps to maintain and support cardiovascular health. Helps to reduce the frequency of migraine headaches and associated nausea and vomiting when taken as a prophylactic.”
- Change suggested usage from “Adults: Take 1 tablet 1-3 times daily with meals or as directed by your healthcare practitioner. Allow tablet to dissolve in mouth and then swallow.” To Adults: Take 1 tablet 1-3 times daily with meals or as directed by your healthcare practitioner. For migraine prophylaxis: Take 2-3 tablets daily with a meal or as directed by your healthcare practitioner. Use for at least 3 months to see beneficial effects. Allow tablet to dissolve in mouth and then swallow.”
- Change tablet size from TAB7 to TAB32.
- Change bottle size from 150cc HDPE to 275cc HDPE.
- Change label size from 6.125” x 2.125” to 7.25” to 2.5”.
Label updated from V3 to V5
|
10/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ascorbplex 1000 Buffered |
7563-90HYC-C |
No change |
Reformulation: Revise excipients / Non-Medicinal Ingredients to add hyprolose, update tablet coating & update order.
- Change tablet coating FROM (polyvinyl alcohol, talc, polyethylene glycol, polysorbate 80) to (hypromellose, glycerin).
Label updated from V3 to V4
|
10/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ultra Balance III Tablets |
200568-180HYC-C |
|
Reformulation: add hyprolose (excipient) for improved tableting performance
Label updated from V2 to V3
|
8/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Vegetarian Enzyme |
7048-60HYC-C |
No change |
Reformulation: revise tablet coating
- tablet coating ingredients changed from polyvinyl alcohol, talc, polyethylene glycol & polysorbate 80 to hypromellose & glycerin
Label updated from V2 to V3
|
7/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Inflaguard |
INF-HYC-C |
|
Reformulation: revise tablet excipients & change tablet shape for improved manufacturing
- remove ethylcellulose
- add hyprolose
- revise tablet shape/size from 0.3125'' x 0.750'' modified oval shape to 0.375'' x 0.875'' modified oval (tablet thickness reduced)
Label updated from V2 to V3
|
3/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Flavonall |
FVA-HYC-C |
No change |
Reformulation: revise potency of green tea leaf extract
- update green tea leaf extract potency label claim from 20% polyphenols to 45% EGCG
Reduce recommended dose from 1 tablet 2 times daily to 1 tablet daily
Increase bottle size from 120cc to 150cc
Label updated from V2 to V4
|
1/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
MAGNESIUM GLYCINATE 100 MG |
7575-120HYC-C |
|
Reformulation: remove magnesium oxide as source of magnesium, revise excipients & change tablet shape
- magnesium source revised from magnesium glycinate/magnesium oxide to magnesium glycinate only
- remove cellulose & stearic acid
- remove dibasic calcium phosphate dihydrate, mangesium stearate
- add ascorbyl palmitate, carnauba wax
Tablet size change from 0.375” X 0.875” modified oval to 0.300” X 0.750” capsule shape.
New Item# 202559-120HYC
New UPC: 3 10539 97904 4
New label V1
|
1/1/2020 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ferro-C |
7035-60HYC-C |
No change |
Reformulation: revise source of vitamin E
- change vitamin E source from vitamin E succinate (d-alpha tocopheryl succinate) to vitamin E acetate (d-alpha tocopheryl acetate)
Label updated from V3 to V4
|
12/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Optimized Curcumin |
202028-60HYC-C |
|
Reformulation: change to soy-free version of Longvida® Optimized Curcumin
- excipient change from soy lecithin to sunflower lecithin
- removed soy allergen warning from product label
New Item# 202524-60HYC-C
New Label V1
|
11/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
JOINT TENDON LIGAMENT I |
201691-90HYC-C |
No change |
Reformulation: excipient change, remove dibasic calcium phosphate dihydrate
Label updated from V2 to V3
|
10/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Methyl B12 Plus |
202273-90HYC-C |
No change |
Reformulation: updated excipients & flavouring to allow for sale/marketing in EU
- revised flavourings from natural cherry flavour to cherry/mixed berry flavour
- added hyprolose (tablet binder) & malic acid (acidifier)
Label updated from V1 to V2
|
10/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Klean Recovery |
KA57633P-1138HYC-C |
|
Reformulation: revise protein source (increase whey protein, remove fish protein)
- increase whey protein isolate from 6.7 g (providing 5.72 g protein) to 11.9 g (providing 10 g protein)
- remove fish protein hydrolysate
- reduce dextrose from 20 g to 19.5 g
- reduce D-fructose from 20 g to 19.5 g
Packaging Change from sachet (fill weight: 1138 g) to bottle (fill weight: 1092 g)
Serving/scoop size changed from 56.9 g to 54.6 g
New Item# KA57695P-1092HYC-C
New NPN: 80086850
New UPC: 3 10539 97849 8
|
9/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Lipotrol |
81158-60HYC-C |
No change |
Reformulation: revise bromelain potency, revise quantities of active ingredient label claims
- Niacin increased from 169 mg to 187.5 mg
- Free Plant Sterols increased from 75 mg to 100 mg
- Choline revised from 34 mg to 32.5 mg
- Inositol increased from 42.5 mg to 37.5 mg
- Bromelain label claim revised from 0.25 mg (4350000 FCC PU) to 25 mg (900000 FCC PU)
- Papain potency increased from 227500 FCC PU to 300000 FCC PU
- Coenzyme Q10, Taurine, Ginkgo Leaf, Cayenne Fruit, Trypsin increased from 0.01 mg to 1 mg
- L-carnitine increased from 0.01 mg to 0.68 mg
Revise recommended dose from 1-2 tablets / day to 2 tablets / day
New NPN: 80088804
Label updated from V1 to V2
|
7/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Estromend |
201353-120HYC-C |
No change |
Reformulation: revise Black Cohosh Extract raw material
- increase extract ratio from 10:1 to 18:1
Update label version from V2 to V3
|
5/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
TestoQuench for Men |
201351-120HYC-C |
|
Reformulation: update formulation due to inability to reliably source Piper cubeba
- remove Cubeb (Piper cubeba) fruit
Add BioPerine® logo to label
New Item# 202410-120HYC-C
New NPN: 80088089
New UPC: 3 10539 97869 6
New label V1
|
5/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Adreno Mend |
200529-120HYC-C |
No change |
Reformulation: revise Rhodiola rosea root standardized extract & minor excipient revision
- Replace Rhodiola rosea 5% rosavins with Rhodiola rosea root extract 3% rosavins/2% salidroside, increase label claim quantity from 50 mg to 80 mg / capsule
- update Eleuthero extract ratio from 8.3:1 to 10:1
- update Magnolia extract ratio from 15:1 to 10:1
- update Forskohlii extract ratio from 6:1 to 2.5 - 3.5:1
- add potency claim for Sensoril™ Ashwagandha (32% withania oligosaccharides, 8% withanolides)
- remove dibasic calcium phosphate dihydrate
New NPN: 80091122
Update label from V2 to V3
|
5/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ultra Balance® III with Copper and Iron |
200577A-180HYC-C |
No change |
Reformulation: excipient change
- revise tablet coating ingredients from polyvinyl alcohol, talc, polyethylene glycol & polysorbate 80 to hypromellose & glycerin
- add sea salt as non-medicinal ingredient
Revise label claim quantities of active ingredients
- Vitamin E revised from 45 mg AT to 44 mg AT
- Thiamine revised from 17 mg to 16 mg
- Niacin revised from 7 mg to 6 mg
- Vitamin B6 revised from 17 mg to 16 mg
- Vitamin B12 revised from 17 mcg to 16 mcg
- Choline bitartrate claim (25 mg) revised to Choline 10 mg
- Copper revised from 0.3 mg to 333 mcg
- Molybdenum revised from 17 mcg to 16 mcg
- Potassium revised from 17 mg to 16 mg
- Glutamic acid revised from 3.3 mg to 3 mg
- N-acetylcysteine revised from 1.5 mg to 1 mg
- Vanadium revised from 8.3 mcg to 8 mcg
New NPN: 80084232
Update label from V2 to V3
|
5/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ultra Balance® III (tablets) |
200568-180HYC-C |
No change |
Reformulation: excipient change (add hyprolose), revise tablet coating
- tablet coating ingredients changed from polyvinyl alcohol, talc, polyethylene glycol & polysorbate 80 to hypromellose & glycerin
Update label from V2 to V3
|
5/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ultra Preventive® X |
200569-240HYC-C/200569-120HYC-C |
|
Reformulation: Update label claim quantities for multiple active ingredients, including vitamin A, beta-carotene, vitamin C, vitamin E, thiamine, riboflavin, vitamin B6.
- Add additional sources of vitamin B12 (add adenosylcobalamin & hydroxocobalamin).
- Add lutein, zeaxanthin, lycopene.
- Remove PABA, L-cysteine hydrochloride, glutamic acid, methionine, maritime pine bark, rose hips (dog rose)
- Revised tablet coating, replacing polyethylene glycol, polysorbate 80 & talc with purified water, hypromellose, glycerin
New item# 202331-240HYC-C (240's) 202331-120HYC-C (120's)
New NPN: 80087785
New UPC: 3 10539 97858 0 (240's) New UPC: 3 10539 97857 3 (120's)
New label V1
|
4/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ferro-C |
7035-60HYC-C |
No change |
Reformulation: revise quantity and source of vitamin E from dl-alpha tocopheryl acetate to d-alpha tocopherol acetate
- increase label claim for vitamin E from 7.3 mg AT (16 IU) to 10.05 mg AT
- reduce recommended daily dose from 1-2 tablets daily to 1 tablet daily
New NPN: 80090131
Update label version from V2 to V3
|
4/1/2019 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Glucoplex |
GST-HYC-C |
No change |
Reformulation: revise source of thiamine
- change source of thiamine from thiamine pyrophosphate to thiamine hydrochloride to ensure reliable material supply
Updated label version from V2 to V4
|
11/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Cal-6+Mag |
7015-90HYC-C/7015-250HYC-C |
|
Reformulation: revise excipients to improve manufacturing processability
- remove magnesium stearate
- add carnauba wax and ascorbyl palmitate
Increase vitamin C label claim from 16.7 mg to 26.6 mg
New item #202396-90HYC-C (90's) 202396-250HYC-C (250's)
New NPN: 80086088
New label V1
|
10/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
DIM Enhanced |
201208-30HYC-C |
|
Reformulation: Raw material change for BioResponse DIM - change source of phosphatidylcholine (excipient) from soy to sunflower
New Item# 202364-30HYC-C
Revise label risk information for green tea (additional risk information added)
New label V2
|
10/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Uro-Pro |
82044-60HYC-C |
No change |
Reformulation: Saw palmetto raw material change
- increase Saw Palmetto Fruit Extract standardization from 30% fatty acids to 35% fatty acids
Update label version from V2 to V3
|
8/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Quercetin-Bromelain |
QBC-HYC-C |
No change |
Reformulation: revise bromelain, revise excipients
- add hydroxypropyl cellulose (hyprolose) excipient
- revise bromelain quantity from 0.2 mg to 50 mg, revise enzyme potency from 3,000,000 FCC PU to 1,800,000 FCC PU
New NPN: 80081046
Revise label version from V2 to V3
|
7/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Ultrazyme |
7022-60HYC-C |
No change |
Reformulation: revise bromelain
- revise bromelain quantity from 88.25 mg to 25 mg, revise enzyme potency from 1,500,000 FCC PU to 900,000 FCC PU per tablet
New NPN: 80084139
Revise label version from V2 to V3
|
7/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Brain Energy |
98723-60HYC-C |
No change |
Reformulation: Rhodiola raw material change
- Change Rhodiola Root Std. Extract standardization from 1% rosavins/0.8% salidroside to 3% rosavins/2% salidroside
Update label version from V2 to V3
|
7/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Corvalen |
57451P-280HYC-C |
No change |
Label Change: update label from V2 to V3
- revise trademark from Corvalen logo to Bioenergy Ribose logo
|
5/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Corvalen M |
57452P-340HYC-C |
No change |
Reformulation: revise source of magnesium, change to scoop serving size
- magnesium source changed from magnesium gluconate to magnesium citrate
- scoop size increased from 6.1 g to 6.2 g
- quantity per bottle increased from 340 g to 347 g
Label version updated from V2 to V3
|
5/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
PMS Support with BioResponse DIM |
201715-60HYC-C |
|
Reformulation: BioResponse DIM® ingredient updated to remove soy (allergen).
- updated non-medicinal ingredients: Hypromellose, cellulose, magnesium stearate, silica, starch, vitamin E, phosphatidylcholine (from sunflower)
- label version updated from V1 to V2, remove soy allergen warning
|
4/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Seditol Plus |
99446-30HYC-C |
|
Reformulation: change to passionflower & lemon balm ingredients
- revise passionflower from powder to aerial parts extract (6 : 1 extract ratio) quantity to 45 mg
- reduce lemon balm extract to 5 mg / capsule
New NPN: 80079425, new item#
|
4/1/2018 |
11/25/2020 |
|
|---|
| Douglas Laboratories |
Pan-Ox-5 |
7917-90HYC-C |
|
Label Change: revise recommended dose from 1 tablet to 3 tablets
Revise Lipase Activity - reduce from 1500 USP to 600 USP units (due to RM vendor specification change)
Remove excipient: commiphora myrrha resin extract
|
12/1/2017 |
11/25/2020 |
|
|---|
