Label: SLEEP-AID MAXIMUM STRENGTH- diphenhydramine hcl capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-2300-8 - Packager: ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 14, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Use
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Warnings
Do not give to children under 12 years of age.
Ask a doctor before use if you have
- emphysema
- chronic bronchitis
- glaucoma
- difficulty in urination due to an enlargement of the prostate gland
- Directions
- Other information
- Questions or comments?
- Inactive ingredients
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Principal Display Panel
*Compare to the active ingredient in Maximum Strength Unisom® SleepGels®
Maximum Strength Sleep-Aid
Diphenhydramine HCl
Helps to reduce difficulty falling asleep
50 mg EACH
SOFTGELS
Distributed by:
Greenbrier International, Inc.
Chesapeake, VA 23320
THIS PRODUCT IS SEALED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.
- Product Label
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INGREDIENTS AND APPEARANCE
SLEEP-AID MAXIMUM STRENGTH
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-2300 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 13mm Flavor Imprint Code P50;A99 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-2300-8 1 in 1 CARTON 1 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/06/2010 Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518) Registrant - P and L Development of New York Corporation (800014821)