DIPHENHIST- diphenhydramine hydrochloride liquid 
Rebel Distributors Corp

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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Diphenhist

Drug Facts

Active ingredient (in each 5mL teaspoonful)

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

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

  • you may get very drowsy
  • 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 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 teaspoonfuls
children 6 to under 12 years1 - 2 teaspoonfuls
children under 6do not use

Other information

Inactive ingredients

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

Questions or comments?

call 1-800-645-2158, 9 am - 5pm ET, Monday - Friday

PRINCIPAL DISPLAY PANEL

COMPARE TO
ACTIVE INGREDIENT IN
BENADRYL®
ALLERGY LIQUID*

CHILDREN'S ALCOHOL-FREE
ALLERGY MEDICATION

Diphenhist®

ORAL SOLUTION

Diphenydramine HCI, USP

Antihistamine

For Temporary Relief of

Symptoms of Upper

Respiratory Allergies

and Hay Fever

4 fl oz
(118 mL)

Diphenhist (Diphenhydramine) 12.5mg/5ml

DIPHENHIST 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-184(NDC:0536-0770)
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
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Glycerin (UNII: PDC6A3C0OX)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Water (UNII: 059QF0KO0R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42254-184-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/26/2009
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 3/2012
Document Id: eefc47ff-ed87-4f98-9fa2-9cb1a0793ba9
Set id: eefc47ff-ed87-4f98-9fa2-9cb1a0793ba9
Version: 1
Effective Time: 20120320
 
Rebel Distributors Corp