Label: UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride tablet, chewable
- NDC Code(s): 41167-0014-0, 41167-0014-1
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 9, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
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
- for children under 12 years of age
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0014 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) D&C RED NO. 7 (UNII: ECW0LZ41X8) STARCH, CORN (UNII: O8232NY3SJ) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color pink Score no score Shape ROUND Size 13mm Flavor CHERRY Imprint Code U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0014-0 3 in 1 CARTON 01/01/2008 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41167-0014-1 4 in 1 CARTON 01/01/2008 2 8 in 1 BLISTER PACK; 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 01/01/2008 Labeler - Chattem, Inc. (003336013)