CHILDRENS ALLERGY RELIEF DYE FREE- diphenhydramine hcl liquid

Childrens Allergy Relief Dye Free by

Drug Labeling and Warnings

Childrens Allergy Relief Dye Free by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH 110, LLC. DBA LEADER, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Diphenhydramine HCl 12.5 mg

PURPOSE

Antihistamine

USE(S)

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies :
• runny nose
• itchy, watery eyes 
• sneezing 
• itching of the nose or throat 

WARNINGS

.

DO NOT USE

• to make a child sleepy 
• with any other product containing diphenhydramine, even one used  on skin

ASK A DOCTOR BEFORE USE IF THE CHILD HAS

• glaucoma 
• a breathing problem such as emphysema or chronic bronchitis
• a sodium restricted diet 

ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

taking sedatives or tranquilizers.

WHEN USING THIS PRODUCT

• alcohol, sedatives, and tranquilizers may increase drowsiness 
• marked drowsiness may occur
• excitability may occur especially in children 

KEEP OUT OF REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• take every 4 to 6 hours 
• do not take more than 6 doses in 24 hours 
• use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device

• AGE(yr): DOSE(mL or tsp)
• children under 2 years: do not use
• children 2 to under 6 years: ask a doctor
• children 6 to under 12 years: 1 to 2 tsp (5 mL to 10 mL)

OTHER INFORMATION

• each tsp contains: sodium 5 mg 
• store at 68o -77o F

INACTIVE INGRADIENTS

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol.

QUESTIONS OR COMMENTS?

(609) 860-2600

PRINCIPAL DISPLAY PANEL

NDC: 70000-0693-1

DYE-FREE

Children's Allergy Relief 

Diphenhydramine HCl

12.5mg /5 mL Oral Solution 

Antihistamine

Cherry

Flavored Liquid

4-6 hours/Dose

Relief of:

Sneezing 

Runny Nose 

itchy, water eyes

itchy Throat

or Nose

Alcohol -Free

100% Money Back Guarantee

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF DYE FREE 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0693
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
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0693-1	1 in 1 CARTON	09/13/2024
1		236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/13/2024

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(70000-0693)