Allergy Relief

Drug Labeling and Warnings

Drug Details [pdf]

ALLERGY RELIEF- diphenhydramine hydrochloride solution 
Bio-Pharm, Inc.

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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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 over: 10 - 20mL (25mg to 50mg)
• adults and children 6 to under 12 years of age: 5 - 10mL (12.5mg to 25mg)
• children 2 to 5 years of age: ask a doctor
• children under 2 years of age: Do 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59741-119
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
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Anhydrous Citric Acid (UNII: XF417D3PSL)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
Glycerin (UNII: PDC6A3C0OX)
Cherry (UNII: BUC5I9595W)
SORBITOL (UNII: 506T60A25R)
FD&C Red no. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59741-119-06	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/06/2007	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/06/2007	05/31/2019

Labeler - Bio-Pharm, Inc. (801652546)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Pharm, Inc.		801652546	MANUFACTURE(59741-119) , ANALYSIS(59741-119) , PACK(59741-119) , LABEL(59741-119)

Revised: 8/2018

Document Id: 76f72c19-69ec-4289-9384-f48b01871e89

34390-5

Set id: 965a7271-bb96-4074-aa1a-fd624c5a778b

Version: 2

Effective Time: 20180831