CHILDRENS DYE FREE ALLERGY RELIEF- diphenhydramine hcl solution

Childrens Dye Free Allergy Relief by

Drug Labeling and Warnings

Childrens Dye Free Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, LNK International, 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:
  • 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

FREE
FROM
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

OUR PROMISE
Dye Free

DOSAGE CUP INCLUDED

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

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

Rite Aid 44-018

 

INGREDIENTS AND APPEARANCE

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

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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

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: 11822-0918-1	1 in 1 CARTON	05/01/2023
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	05/01/2023

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(11822-0918) , pack(11822-0918)