Label: BENADRYL ALLERGY LIQUI-GELS- diphenhydramine hydrochloride capsule, liquid filled
- NDC Code(s): 50580-228-24, 50580-228-48, 50580-228-49
- 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 May 17, 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 capsule)
- 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 ALLERGY LIQUI-GELS
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-228 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 GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white (Clear) Score no score Shape OVAL Size 15mm Flavor Imprint Code BENADRYL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-228-24 2 in 1 CARTON 03/01/2009 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-228-48 2 in 1 PACKAGE 02/01/2023 2 4 in 1 CARTON 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-228-49 3 in 1 PACKAGE 06/19/2023 3 4 in 1 CARTON 3 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 03/01/2009 Labeler - Johnson & Johnson Consumer Inc. (878046358)