Label: CHILDRENS BENADRYL CHEWABLES- diphenhydramine hydrochloride tablet, chewable
- NDC Code(s): 50580-232-01
- Packager: Johnson & Johnson Consumer 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 March 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
-
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
- find right dose on chart below
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
Age (yr) Dose (chewable tablets) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 1 to 2 chewable tablets (12.5 mg to 25 mg) adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg) - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CHILDRENS BENADRYL CHEWABLES
diphenhydramine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-232 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 ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 7 (UNII: ECW0LZ41X8) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ACACIA (UNII: 5C5403N26O) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SUCRALOSE (UNII: 96K6UQ3ZD4) TARTARIC ACID (UNII: W4888I119H) CROSPOVIDONE (UNII: 2S7830E561) D&C RED NO. 30 (UNII: 2S42T2808B) Product Characteristics Color purple Score no score Shape ROUND Size 13mm Flavor GRAPE Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-232-01 2 in 1 CARTON 07/11/2016 1 10 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 07/11/2016 Labeler - Johnson & Johnson Consumer Inc. (878046358)