Label: BANOPHEN- diphenhydramine hcl liquid
- NDC Code(s): 63187-315-04
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-1228
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)*
- Purpose
- Uses
-
Warnings
Do not use
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- to make a child sleepy
Ask a doctor before use if the child has
- •
- a breathing problem such as chronic bronchitis
- •
- glaucoma
- •
- a sodium-restricted diet
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Directions
- •
- find right dose on chart below
- •
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- •
- take every 4 to 6 hours
- •
- do not take more than 6 doses in 24 hours
Age (yr)
Dose
children under 2 years
do not use
children 2 to 5 years
do not use unless directed by a doctor
children 6 to 11 years
5 to 10 mL (1 to 2 tsp)
Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BANOPHEN
diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-315(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) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) 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:63187-315-04 1 in 1 CARTON 02/02/2015 1 118 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 Drug M012 11/20/2006 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-315)