Label: BENADRYL- diphenhydramine hydrochloride tablet, film coated
- NDC Code(s): 71205-521-06
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 50580-226
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
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- to make a child sleepy
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- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
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- a breathing problem such as emphysema or chronic bronchitis
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENADRYL
diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-521(NDC:50580-226) 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 Carnauba Wax (UNII: R12CBM0EIZ) Croscarmellose Sodium (UNII: M28OL1HH48) D&C red no. 27 aluminum lake (UNII: ZK64F7XSTX) Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP) Hypromellose, Unspecified (UNII: 3NXW29V3WO) Magnesium Stearate (UNII: 70097M6I30) Microcrystalline Cellulose (UNII: OP1R32D61U) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) Polysorbate 80 (UNII: 6OZP39ZG8H) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color PINK Score no score Shape OVAL Size 11mm Flavor Imprint Code B;WL;25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-521-06 3 in 1 BAG 01/01/2021 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/01/2008 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-521) , RELABEL(71205-521)