Label: DIPHENHYDRAMINE HCL 12.5MG ANTIHISTAMINE- diphenhydramine hydrochloride bar, chewable
- NDC Code(s): 50488-4125-1
- Packager: Alexso, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 24, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT (in each soft chew)
- PURPOSE
- USES
-
WARNINGS
Do not use
- To make child sleepy
- 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
- To make child sleepy
-
DIRECTIONS
Adults and children 12 years and over:
- Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctor
- Do not take more than 6 times in 24 hours
- Chew each soft chew thoroughly before swallowing
Children 6 to 11 years:
- Take 1 to 2 soft chews (12.5 mg to 25 mg) every 4 to 6 hours, or as directed by a doctor.
- Do not take more than 6 times in 24 hours
- Chew each soft chew thoroughly before swallowing
Children under 6 years: Do not use
- Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctor
- OTHER INFORMATION
- Inactive ingredients:
- Questions or comments?
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL 12.5MG ANTIHISTAMINE
diphenhydramine hydrochloride bar, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-4125 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTITOL (UNII: D65DG142WK) MALTODEXTRIN (UNII: 7CVR7L4A2D) MINERAL OIL (UNII: T5L8T28FGP) NEOTAME (UNII: VJ597D52EX) WATER (UNII: 059QF0KO0R) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM CHLORIDE (UNII: 451W47IQ8X) STARCH, CORN (UNII: O8232NY3SJ) CORN SYRUP (UNII: 9G5L16BK6N) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color YELLOW (Light yellow to golden brown) Score no score Shape RECTANGLE Size 18mm Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50488-4125-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/08/2021 Labeler - Alexso, Inc (963338061)