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Childrens Allergy by Dolgencorp, LLC

Dosage form: solution
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Dolgencorp, LLC
NDC Code: 55910-991

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, USP 12.5 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • 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
  • 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 right away. (1-800-222-1222)

Directions
  • find right dose on chart below
  • mL = milliliter 
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

Age (yr)
Dose (mL)
children under 2 years
do not use
children 2 to 5 years
do not use unless
directed by a doctor
children 6 to 11 years
5 mL to 10 mL

Attention: Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information
  • each 5 mL contains: sodium 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD & C red no. 40, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Questions or Comments?

1-888-309-9030

DISTRIBUTED BY
DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL Bottle)

DG® health
Compare to the active ingredient of Children's Benadryl® Allergy Liquid*
For Ages 6 to 11 Years
Children’s
Allergy
Diphenhydramine Hydrochloride 12.5 mg/5 mL Oral Solution
Antihistamine

  • Alcohol free

Relieves runny nose, sneezing, itchy throat & watery eyes
Cherry Flavor
8 FL OZ (236 mL)
12.5 mg per 5 mL

CHILDRENS ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-991
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 
D&C RED NO. 33 
FD&C RED NO. 40 
CHERRY 
HIGH FRUCTOSE CORN SYRUP 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SUCRALOSE 
Product Characteristics
ColorRED (Reddish to pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55910-991-201 BOTTLE in 1 CARTON
1236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/18/2017
Labeler - Dolgencorp, LLC (068331990)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(55910-991)

 
Dolgencorp, LLC

← See all Childrens Allergy brands

Medically reviewed on Mar 18, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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