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Allergy Relief by Bio-Pharm, Inc.

Medically reviewed on May 21, 2018

Dosage form: solution
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Bio-Pharm, Inc.
NDC Code: 59741-119

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.

Allergy Relief

Drug Facts

Active ingredient (in each 5mL TSP (teaspoon))

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use
  • with any other product containing diphenhydramine, including one applied topically
  • to make a child sleepy

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 (1-800-222-1222) right away.

Directions
  • use only enclosed dosing cup to dose this product
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours
adults and children 12 years of age and over2-4 TSP (10mL - 20mL)
adults and children 6 to under 12 years of age1-2 TSP (5mL - 10mL)
children 2 to 5 years of ageask a doctor
children under 2 years of agedo not use

Other information
  • each TSP (5 mL) contains: sodium 4 mg
  • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

866-845-1611

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

COMPARE TO ACTIVE INGREDIENT IN
CHILDREN'S BENADRYL® ALLERGY LIQUID*

NDC 59741-119-10

ASSURED

CHILDREN'S

Allergy
Relief

Diphenhydramine HCl
Oral Solution, USP

Antihistamine

AGES 6 +

  • Alcohol Free
  • Sugar Free

Cherry flavor

Relieves Itchy Throat / Nose,
Itchy, Watery Eyes, Runny
Nose & Sneezing

(12.5 mg per 5 mL)

4 FL OZ
(118 mL)

ALLERGY RELIEF 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-119
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Saccharin Sodium 
SODIUM CITRATE 
Anhydrous Citric Acid 
POLYSORBATE 20 
Glycerin 
Cherry 
SORBITOL 
Water 
FD&C Red no. 40 
D&C RED NO. 33 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59741-119-101 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33605/16/2014
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(59741-119), ANALYSIS(59741-119), PACK(59741-119), LABEL(59741-119)

 
Bio-Pharm, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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