Label: UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule
- NDC Code(s): 41167-0067-0, 41167-0067-2
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 9, 2023
If you are a consumer or patient 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 SLEEPMINIS NIGHTTIME SLEEP-AID
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0067 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) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GELATIN (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (with a blue band) Score no score Shape OVAL Size 14mm Flavor Imprint Code SleepMinis Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0067-2 1 in 1 CARTON 04/01/2015 07/31/2020 1 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:41167-0067-0 1 in 1 CARTON 04/01/2015 2 60 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 04/01/2015 Labeler - Chattem, Inc. (003336013)