Label: SLEEP TABS FOR NIGHTTIME USE- diphenhydramine hcl tablets tablet
- NDC Code(s): 69168-247-24
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 26, 2018
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Do not use
- with any other products containing diphenhydramine, including one used on skin
- in children under 12 years of age
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
When using this product
- marked drowsiness may occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
SLEEP TABS FOR NIGHTTIME USE
diphenhydramine hcl tablets tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-247 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape ROUND Size 10mm Flavor Imprint Code AZ247 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-247-24 24 in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product 04/28/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/28/2015 Labeler - Allegiant Health (079501930)