Label: BANOPHEN- diphenhydramine hcl capsule
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NDC Code(s):
71335-0081-0,
71335-0081-1,
71335-0081-2,
71335-0081-3, view more71335-0081-4, 71335-0081-5, 71335-0081-6, 71335-0081-7, 71335-0081-8, 71335-0081-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0904-5307
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 5, 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
-
WARNINGS
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
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Directions
- Take every 4-6 hours
- Do not take more than 6 doses in 24 hours
adults and children 12 years of age and over Take 1 capsule (50 mg) children 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?
- SPL UNCLASSIFIED SECTION
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HOW SUPPLIED
NDC: 71335-0081-1: 15 Capsules in a BOTTLE
NDC: 71335-0081-2: 20 Capsules in a BOTTLE
NDC: 71335-0081-3: 30 Capsules in a BOTTLE
NDC: 71335-0081-4: 10 Capsules in a BOTTLE
NDC: 71335-0081-5: 6 Capsules in a BOTTLE
NDC: 71335-0081-6: 100 Capsules in a BOTTLE
NDC: 71335-0081-7: 90 Capsules in a BOTTLE
NDC: 71335-0081-8: 60 Capsules in a BOTTLE
NDC: 71335-0081-9: 2 Capsules in a BOTTLE
NDC: 71335-0081-0: 12 Capsules in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BANOPHEN
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0081(NDC:0904-5307) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 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 Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC;836 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0081-1 15 in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2020 2 NDC:71335-0081-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018 3 NDC:71335-0081-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2018 4 NDC:71335-0081-4 10 in 1 BOTTLE; Type 0: Not a Combination Product 09/09/2019 5 NDC:71335-0081-5 6 in 1 BOTTLE; Type 0: Not a Combination Product 08/07/2019 6 NDC:71335-0081-6 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/07/2018 7 NDC:71335-0081-7 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 8 NDC:71335-0081-8 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 9 NDC:71335-0081-9 2 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 10 NDC:71335-0081-0 12 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/02/2009 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0081) , RELABEL(71335-0081)