CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride solution
CVS Pharmacy

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.

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CVS Childrens Allergy Relief

Drug Facts

Active Ingredients (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 your 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

do not take more than 6 doses in any 24 hour period.
give the recommended number of vials below following the instructions ....under “How to Open and Use” on the side panel.
empty each Single-Use Vial required of all liquid when dosing.

this product does not contain directions or complete warnings for adult use.

Dosing Chart
Age	Dose (mL)
Under 6 years	Do not use unless directed by a doctor
6-11 years	1 - 2 Single-Use Vials (5 mL Each) Every 4 - 6 hours Do not exceed 12 Vials in 24 hours

Inactive Ingredients

Citric Acid, Glycerin, Mixed Berry Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sorbitol, Strawberry Flavor, Sucralose, Tri-Sodium Citrate, Xanthan Gum.

Questions or Comments?

1-800-719-9260

Other Information

each Single-Use Vial contains 15mg of sodium.
store at 20-25 °C (68-77 °F)
tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken.

Package Labeling:

Package

CHILDRENS ALLERGY RELIEF
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-261
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-261-01	1 in 1 BOX	12/18/2018	07/31/2022
1		100 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/18/2018	07/31/2022

Labeler - CVS Pharmacy (062312574)

Revised: 12/2022

Document Id: f0868810-9d6b-d595-e053-2a95a90a3f64

Set id: 37699001-8f1b-434b-ae75-bbd9c8f0f46a

Version: 8

Effective Time: 20221223

CVS Pharmacy