Label: BANOPHEN- diphenhydramine hcl capsule
- NDC Code(s): 0904-5307-60, 0904-5307-80
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 12, 2024
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- 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
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Major
NDC 0904-5307-80
BENOPHEN
Complete Allergy Medication
Diphenhydramine HCl 50 mg
ANTIHISTAMINE
For the temporary relief from symptoms of:
• Upper Respiratory Allergies • Hay Fever1000 CAPSULES
Each Capsule Individually Banded For Your Protection
THIS LARGE PACKAGE SIZE FOR DISPENSING PURPOSE ONLY
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INGREDIENTS AND APPEARANCE
BANOPHEN
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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 (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:0904-5307-60 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2009 2 NDC:0904-5307-80 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/02/2009 Labeler - Major Pharmaceuticals (191427277)