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 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 over	2-4 TSP (10mL - 20mL)
adults and children 6 to under 12 years of age	1-2 TSP (5mL - 10mL)
children 2 to 5 years of age	ask a doctor
children under 2 years of age	do 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)

Principal Display Panel - 118 mL Bottle Carton

ALLERGY RELIEF
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59741-119
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
Anhydrous Citric Acid (UNII: XF417D3PSL)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
Glycerin (UNII: PDC6A3C0OX)
Cherry (UNII: BUC5I9595W)
SORBITOL (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
FD&C Red no. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59741-119-10	1 in 1 CARTON	05/16/2014	02/29/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/16/2014	02/29/2016

Labeler - Bio-Pharm, Inc. (801652546)

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

Revised: 8/2018

Document Id: 669bbbe5-0122-47a2-8494-bc03b9cae57e

Set id: 413e3c5e-aa04-4700-8408-98059c9342f6

Version: 2

Effective Time: 20180824

Bio-Pharm, Inc.