Label: BANOPHEN- diphenhydramine hcl liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0904-1228-00, 0904-1228-20 - Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
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 September 25, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, including one applied topically.
Ask a doctor before use if you have
- glaucoma
- a sodium restricted diet
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
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Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
- use only with enclosed dosing cup. Do not use with any other device
- find right dose on chart below
- mL = milliliter
adults and children 12 years and over 10-20mL (25 mg to 50 mg) children 6 to under 12 years 5-10mL (12.5 mg to 25 mg) children 2 to 5 years of age do not use unless directed by a doctor children under 2 years of age do not use - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
BANOPHEN
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-1228 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) CHERRY (UNII: BUC5I9595W) Product Characteristics Color red (Bluish-Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-1228-20 1 in 1 CARTON 11/20/2006 01/31/2021 1 NDC:0904-1228-00 118 mL in 1 BOTTLE; 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 11/20/2006 Labeler - Major Pharmaceuticals (191427277)