Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled
- NDC Code(s): 70692-784-02
- Packager: Strive Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
-
WARNINGS
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drugs that cause drowsiness such as antihistamines and night-time cold/flu products
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as asthma, emphysema or chronic bronchitis
- heart disease
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid
When using this product
- drowsiness may occur
- avoid alcoholic drinks and other drugs that cause drowsiness
Stop use and ask a doctor if
- sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-784 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 WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SORBITAN (UNII: 6O92ICV9RU) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) POVIDONE K30 (UNII: U725QWY32X) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color purple Score no score Shape OVAL (Oblong) Size 14mm Flavor Imprint Code 784 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-784-02 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 08/20/2018 Labeler - Strive Pharmaceuticals Inc. (080028013)