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Allergy Relief by Bio-Pharm, Inc.

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 5 mL)

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of 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
  • a sodium-restricted diet

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
  • use caution 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. (1-800-222-1222)

Directions
  • take every 4 to 6 hours
  • use only with enclosed dosing cup. Do not use with any other device
  • do not take more than 6 doses in 24 hours
  • mL = milliliter
adults and children 12 years of age and over10 - 20mL (25mg to 50mg)
adults and children 6 to under 12 years of age5 - 10mL (12.5mg to 25mg)
children 2 to 5 years of ageask a doctor
children under 2 years of ageDo not use

Other information
  • each 5mL contains: sodium 7 mg
  • 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, polysorbate20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

866-845-1611

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 59741-119-06
TAMPER-EVIDENT

ASSURED

Allergy
Liquid

Antihistamine

Alcohol
Free

Diphenhydramine
HCl USP
12.5 mg / 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, UNSPECIFIED FORM 
Anhydrous Citric Acid 
POLYSORBATE 20 
Glycerin 
Cherry 
SORBITOL 
FD&C Red no. 40 
D&C RED NO. 33 
Water 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59741-119-06118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/06/2007
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(59741-119), ANALYSIS(59741-119), PACK(59741-119), LABEL(59741-119)

Revised: 10/2016
 
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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