BANOPHEN- diphenhydramine hydrochloride liquid 
Atlantic Biologicals Corps
Reference Label Set Id: 23e653b4-30f4-4038-82ce-78863c3f3101

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.

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Banophen

Drug Facts

Active ingredient (in each teaspoonful (5 mL))

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to under 12 years1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 years of agedo not use unless directed by a doctor
children under 2 years of agedo not use

Other information

Inactive ingredients

artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Questions or comments?

(800) 616-2471

HOW SUPPLIED

Product: 17856-5174

NDC: 17856-5174-2 5 mL in a CUP

NDC: 17856-5174-1 10 mL in a CUP, UNIT-DOSE

BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID

Label Image
BANOPHEN 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5174(NDC:0904-5174)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sorbitol (UNII: 506T60A25R)  
FD&C Red no. 40 (UNII: WZB9127XOA)  
Glycerin (UNII: PDC6A3C0OX)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Cherry (UNII: BUC5I9595W)  
Water (UNII: 059QF0KO0R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
D&C Red no. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-5174-272 in 1 CASE09/17/2019
1 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/24/2012
Labeler - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-5174) , REPACK(17856-5174)

Revised: 9/2019
Document Id: 8b549445-7b81-4d30-b030-b508801111f8
Set id: f60f923c-b2d6-4917-98cc-b0a8e3e47239
Version: 6
Effective Time: 20190917
 
Atlantic Biologicals Corps