Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule
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NDC Code(s):
71335-0435-0,
71335-0435-1,
71335-0435-2,
71335-0435-3, view more71335-0435-4, 71335-0435-5, 71335-0435-6, 71335-0435-7, 71335-0435-8, 71335-0435-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0904-5306
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 25, 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:
- runny nose
- sneezing
- itchy, watery eyes
- itchy throat and nose
- Temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
50 MG
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
- sneezing
- runny nose
- itchy, watery eyes
- itchy throat and nose
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
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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
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HOW SUPPLIED
NDC: 71335-0435-1: 30 Tablets in a BOTTLE
NDC: 71335-0435-2: 20 Tablets in a BOTTLE
NDC: 71335-0435-3: 42 Tablets in a BOTTLE
NDC: 71335-0435-4: 24 Tablets in a BOTTLE
NDC: 71335-0435-5: 15 Tablets in a BOTTLE
NDC: 71335-0435-6: 60 Tablets in a BOTTLE
NDC: 71335-0435-7: 10 Tablets in a BOTTLE
NDC: 71335-0435-8: 6 Tablets in a BOTTLE
NDC: 71335-0435-9: 90 Tablets in a BOTTLE
NDC: 71335-0435-0: 100 Tablets in a BOTTLE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0435(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:71335-0435-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/05/2018 2 NDC:71335-0435-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2018 3 NDC:71335-0435-3 42 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 4 NDC:71335-0435-4 24 in 1 BOTTLE; Type 0: Not a Combination Product 11/12/2019 5 NDC:71335-0435-5 15 in 1 BOTTLE; Type 0: Not a Combination Product 01/28/2019 6 NDC:71335-0435-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2020 7 NDC:71335-0435-7 10 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 8 NDC:71335-0435-8 6 in 1 BOTTLE; Type 0: Not a Combination Product 11/14/2019 9 NDC:71335-0435-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 10 NDC:71335-0435-0 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/02/2009 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0435) , RELABEL(71335-0435)