CHILDRENS ALLERGY RELIEF DYE FREE BUBBLE GUM- diphenhydramine hydrochloride liquid

Childrens Allergy Relief by

Drug Labeling and Warnings

Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by FSA Store Inc. (Caring Mills). 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 the 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 20-25ºC (68-77ºF). Do not refrigerate
• Protect from light. Store in outer carton until contents are used.

Inactive ingredients

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

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

For Ages 6-11 Years

Children's Allergy Relief

Diphenhydramine HCI 125 mg/5 mL

Antihistamine Oral Solution

Bubble Gum Flavor

Dye-Free

Alcohol-Free

Relieves:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itching of the nose or throat

Dosing Cup included

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor 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.

Manufactured for FSA Store Inc.

240 W. 37th St., 6th Floor

New York, NY  10018

Packaging Label

Caring Mills Children's Allergy Dye Free Bubble Gum Liquid

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF  DYE FREE BUBBLE GUM
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81522-293
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)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
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: 81522-293-04	1 in 1 CARTON	04/18/2022
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 Drug	M012	04/18/2022

Labeler - FSA Store Inc. (Caring Mills) (049283340)