Label: BENADRYL- diphenhydramine hydrochloride tablet, film coated
Contains inactivated NDC Code(s)
NDC Code(s): 76413-353-24
- Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 50580-226
- 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.
Updated September 24, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
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
- trouble urinating due to an enlarged prostate gland
When using this product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED
INGREDIENTS AND APPEARANCE
diphenhydramine hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-353(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 (UNII: 2LRS185U6K) Aluminum Oxide (UNII: LMI26O6933) 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:76413-353-24 1 in 1 CARTON 09/21/2018 1 2 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 - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Travis County Healthcare District 797039398 RELABEL(76413-353) , REPACK(76413-353)