CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

Childrens Allergy by

Drug Labeling and Warnings

Childrens Allergy by is a Otc medication manufactured, distributed, or labeled by Freds Inc. 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 6 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate
• Protect from light. Store in outer carton until contents are used

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

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

CHILDREN'S ALLERGY

Diphenhydramine HCI 12.5 mg

ANTIHISTAMINE

RELIEVES:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

Alcohol Free

4-6 Hours per Dose

CHERRY Flavored Liquid

FL OZ (mL)

Dosing Cup Included

*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: fred's Inc.

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.fredsinc.com

Product Label

FRED'S PHARMACY Children's Allergy Cherry Flavor

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-092
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)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCROSE (UNII: C151H8M554)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-092-04	1 in 1 BOX	04/30/2015
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	04/30/2015

Labeler - Freds Inc (005866116)