OTC Medication Information: Childrens Dye Free Allergy Relief

CHILDRENS DYE FREE ALLERGY RELIEF- diphenhydramine hydrochloride solution
Rite Aid Corporation

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:
    • 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

  • glaucoma
  • a breathing problem such as chronic bronchitis

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.

Directions

  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided
  • 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

Other information

  • each 5 mL contains: sodium 4 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal Display Panel

SUGAR FREE
ALCOHOL FREE

Compare to the
active ingredient in
Children’s Benadryl®
Dye-Free Allergy*

NDC 11822-0918-1

AGES 6-11
CHILDREN’S
DYE-FREE
ALLERGY RELIEF

DIPHENHYDRAMINE
HCl 12.5 mg / 5 mL
Oral Solution
ANTIHISTAMINE
for relief of:
sneezing,
runny nose,
itchy throat or nose,
itchy, watery eyes

CLEAR BUBBLE
GUM FLAVOR

DOSAGE CUP INCLUDED

4 FL OZ (118 mL)

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Children’s Benadryl® Dye-Free Allergy.
50844 ORG012301836

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY:
RITE AID
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com

SATISFACTION
GUARANTEE
If you’re not satisfied, we’llhappily refund your money.

Rite Aid 44-018
(click image for full-size original)

Rite Aid 44-018

CHILDRENS DYE FREE ALLERGY RELIEF diphenhydramine hcl solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0918
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
TRISODIUM CITRATE DIHYDRATE
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-0918-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (11822-0918-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 05/01/2023
Labeler — Rite Aid Corporation (014578892)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 manufacture (11822-0918), pack (11822-0918)

Revised: 05/2023 Rite Aid Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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