Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
- NDC Code(s): 68788-7589-1, 68788-7589-3, 68788-7589-5
- Packager: Preferred Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5306
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 10, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each banded capsule)
- Purpose
-
Use
25 MG
- •
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- o
- runny nose
- o
- sneezing
- o
- itchy, watery eyes
- o
- itchy throat and nose
- •
- Temporarily relieves these symptoms due to the common cold:
- o
- runny nose
- o
- sneezing
50 MG
- •
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
- o
- sneezing
- o
- runny nose
- o
- itchy, watery eyes
- o
- itchy throat and nose
- WARNINGS
- Ask a doctor before use if you have
- Ask a doctor or pharmacist
- When using this product
- If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- •
- Take every 4-6 hours
- •
- Do not take more than 6 doses in 24 hours
25 MG
adults and children 12 years of age and over
1 to 2 capsules
children 6 years to under 12 years of age
1 capsule
children under 6 years of age
do not use this product in children under 6 years of age
50 MG
adults and children 12 years of age and over
1 capsule
children 6 years to under 12 years of age
Ask a doctor, the proper dosage strength is not available in this package**
**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.
- Other Information
- Inactive Ingredients
- Questions?
- Distributed by
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7589(NDC:0904-5306) 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) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color pink (half pink and half clear with white powder inside) 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:68788-7589-1 10 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 2 NDC:68788-7589-5 15 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 3 NDC:68788-7589-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 341 01/02/2009 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Registrant - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-7589)
