Label: NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled
- NDC Code(s): 41250-696-33, 41250-696-64, 41250-696-80
- Packager: Meijer Distribution 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 April 27, 2021
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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 use
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- for children under 12 years of age
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- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
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- a breathing problem such as emphysema or chronic bronchitis
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-696 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE (clear to light blue) Score no score Shape OVAL Size 13mm Flavor Imprint Code 5V6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-696-64 1 in 1 CARTON 06/02/2020 1 32 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41250-696-80 1 in 1 CARTON 06/04/2020 2 96 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:41250-696-33 1 in 1 CARTON 04/27/2021 3 60 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 06/02/2020 Labeler - Meijer Distribution Inc (006959555)