Label: BENADRYL- diphenhydramine hydrochloride tablet, film coated
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NDC Code(s):
50580-226-50,
50580-226-51,
50580-226-52,
50580-226-53, view more50580-226-54, 50580-226-56, 50580-226-62
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
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 March 20, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- to make a 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BENADRYL
diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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:50580-226-50 1 in 1 CARTON 06/04/2012 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:50580-226-51 2 in 1 CARTON 06/04/2012 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-226-53 2 in 1 POUCH; Type 0: Not a Combination Product 06/04/2012 4 NDC:50580-226-54 60 in 1 CARTON 07/27/2015 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:50580-226-62 4 in 1 CARTON 01/02/2017 5 2 in 1 POUCH; Type 0: Not a Combination Product 6 NDC:50580-226-52 4 in 1 CARTON 06/04/2012 6 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:50580-226-56 3 in 1 PACKAGE 02/01/2013 7 4 in 1 CARTON 7 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/01/2008 Labeler - Johnson & Johnson Consumer Inc. (878046358)