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Childrens Allergy by Freds Inc

Medically reviewed on September 20, 2017

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Freds Inc
NDC Code: 55315-092

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.

Drug Facts

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

CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-092
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
TRISODIUM CITRATE DIHYDRATE 
SUCROSE 
D&C RED NO. 33 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-092-041 BOTTLE, PLASTIC in 1 BOX
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/30/2015
Labeler - Freds Inc (005866116)

 
Freds Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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