Label: SLEEP AID- diphenhydramine hydrochloride tablet, film coated
- NDC Code(s): 56062-431-62, 56062-431-78
- Packager: Publix Super Markets Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 17, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Use
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Warnings
Do not use
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- in 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
When using this product
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- avoid alcoholic drinks
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- drowsiness may occur
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- do not drive a motor vehicle or operate machinery
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SLEEP AID
diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-431 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Light Blue) Score no score Shape OVAL Size 11mm Flavor Imprint Code L431 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-431-62 12 in 1 CARTON 05/09/2002 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:56062-431-78 1 in 1 CARTON 08/29/2011 2 100 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 Drug M010 07/24/2001 Labeler - Publix Super Markets Inc (006922009)