Label: SLEEP AID- diphenhydramine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 59970-079-16 - Packager: Navarro Discount Pharmacies,LLC
- 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 February 8, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Do not use
- in 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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Package label
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INGREDIENTS AND APPEARANCE
SLEEP AID
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59970-079 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code BD Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59970-079-16 2 in 1 BOX 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 02/01/2013 Labeler - Navarro Discount Pharmacies,LLC (094930963)