Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
- NDC Code(s): 50090-6405-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0904-7237
- 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 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
-
WARNINGS
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 INGREDIENT
- Questions or comments?
-
SPL UNCLASSIFIED SECTION
Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268
Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.
To preserve quality and freshness, keep bottle tightly closed.
KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE
TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING. - HOW SUPPLIED
- DIPHENHYDRAMINE HYDROCHLORIDE
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-6405(NDC:0904-7237) 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 D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color pink (Half pink and half clear with white powder inside and sealed with red band) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC;835 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-6405-0 32 in 1 BOX, UNIT-DOSE 03/22/2023 1 1 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 04/14/2022 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-6405)