CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride solution

Childrens Allergy Relief by

Drug Labeling and Warnings

Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
  
  • Age: Dose (mL)
  • Under 2 years: Do not use
  • 2-6 years: Consult a doctor
  • 6-12 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 12mg 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:

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-261
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
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)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)

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

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

Labeler - CVS Pharmacy (062312574)