Label: SLEEPEZE MINIS- diphenhydramine hydrochloride tablet
- NDC Code(s): 63029-926-16
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated January 18, 2024
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
-
Warnings
Do not use
●if you are elderly, as this drug may cause excitation rather than sedation ●with any other product containing diphenhydramine, even one used on skin ●in children under 12 years of age
Ask a doctor or pharmacist before use if you
●have ▪a breathing problem such as emphysema or chronic bronchitis ▪glaucoma ▪difficulty urinating ●take sedatives or tranquilizers ●are pregnant or breastfeeding
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SLEEPEZE MINIS
diphenhydramine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-926 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color blue Score no score Shape ROUND Size 8mm Flavor Imprint Code S;M Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-926-16 1 in 1 CARTON 12/03/2018 1 16 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 12/03/2018 Labeler - Medtech Products Inc. (122715688)