Label: MAXIMUM STRENGTH NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-624-02 - Packager: CVS PHARMACY, INC.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated December 7, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
- Purpose
- Use
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Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH NIGHTTIME SLEEP AID
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-624 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 GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color blue (clear) Score no score Shape CAPSULE (oval) Size 14mm Flavor Imprint Code 206 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-624-02 200 in 1 BOTTLE; Type 0: Not a Combination Product 02/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 02/11/2020 Labeler - CVS PHARMACY, INC. (062312574) Registrant - Spirit Pharmaceuticals LLC (179621011) Establishment Name Address ID/FEI Business Operations MEDGEL PRIVATE LIMITED 677385498 manufacture(69842-624)