Label: UNISOM SLEEPGELS NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled
-
NDC Code(s):
41167-0061-0,
41167-0061-1,
41167-0061-2,
41167-0061-3, view more41167-0061-5, 41167-0061-6
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 9, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
-
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 SLEEPGELS NIGHTTIME SLEEP-AID
diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0061 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, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue Score no score Shape OVAL Size 13mm Flavor Imprint Code UNISOM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0061-0 1 in 1 CARTON 01/01/2007 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41167-0061-1 2 in 1 CARTON 01/01/2007 2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:41167-0061-3 1 in 1 CARTON 01/01/2007 3 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:41167-0061-6 1 in 1 CARTON 01/01/2007 4 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:41167-0061-2 1 in 1 CARTON 09/15/2017 5 100 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:41167-0061-5 1 in 1 CARTON 01/01/2007 6 40 in 1 BOTTLE, PLASTIC; 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 01/01/2007 Labeler - Chattem, Inc. (003336013)