DYE FREE ALLERGY CHILDRENS- diphenhydramine hydrochloride liquid

Dye Free Allergy by

Drug Labeling and Warnings

Dye Free Allergy by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

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

Warnings

Do not use

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

Ask a doctor before use if the child has

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

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• 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 (1-800-222-1222) right away.

Directions

• do not take more than 6 doses in 24 hours
• take every 4 to 6 hours, or as directed by a doctor
• measure only with dosing cup provided. Do not use any other dosing device. 
• mL = milliliter
• keep dosing cup with product 
• find the right dose on the chart below

• age (yr): dose (mL)
• children 6 to 11 years: 5 mL to 10 mL
• children 2 to 5 years: do not use unless directed by a doctor
• children under 2 years: do not use

Other information

• each 5 mL contains: sodium 8 mg
• store between  20-25°C (68-77°F). Do not refrigerate.
• Protect from light. Store in outer carton until contents are used.

Inactive ingredients

anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions or comments?

 Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Children's Benadryl® Allergy

Dye-Free

Children's

Allergy

Antihistamine

Diphenhydramine Hydrochloride 12.5mg / 5 mL Oral Solution

Liquid Medication

Relieves

Runny Nose | Sneezing |

Itchy, Watery Eyes | Itchy Throat

For Ages 6 to 11 Years

Alcohol-Free

Dye-Free

Bubble Gum Flavored

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc,©

43157 W.Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

QUALITY CHOICE Dye-Free Children's Allergy

INGREDIENTS AND APPEARANCE

DYE FREE ALLERGY  CHILDRENS
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-128
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-128-04	1 in 1 BOX	02/29/2016
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)