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Drug Facts
Cvs Health Childrens Allergy Relief Liquid
FDA Label NDC 59779-793
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc. for the product Cvs Health Childrens Allergy Relief (NDC 59779-793). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml blister), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml Blister)
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
Otc - Do Not Use
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
Ask a doctor before use if the child has
- a breathing problem such as chronic bronchitis
- glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
Otc - When Using
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Otc - Keep Out Of Reach Of 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
- break tab on blister
- pour liquid directly into mouth or into teaspoon
- be careful of blister edges to prevent cuts on skin
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
Age (yr) | Dose (tsp) |
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 | 1 to 2 single-dose blisters(12.5mg to 25mg) |
Other Information
- each blister contains: sodium 11 mg
- store at (59-77°F)
- do not use if individual single-dose blisters are torn or broken
- see bottom panel for lot number and expiration date
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
Principal Display Panel
CVS Health ™
Compare to the active ingredient in Children's
Benadryl® *
Dye-Free Liquid
Children’s Allergy Relief
Liquid Medication
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
Antihistamine
alcohol and sugar free
Relief of:
Cherry Flavored
Sugar & Alcohol free
Actual Product size on Side Panel
Single Dose
10 SINGLE DOSE VIALS
This is not a child-resistant package. Keep out of reach of children
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Benadryl® Dye –Free Allergy.
TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL SINGLE-DOSE BLISTER UNIT IS BROKEN OR OPEN |
Distributed by: CVS Pharmacy, Inc.
One CVS Drive,Woonsocket, RI 02895
© 2015CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in the U.S.A.
V-12431
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SNAP BACK AT PERFORATION LINE
POUR INTO MOUTH OR SPOON
Cvs Health Children's Allergy Relief 10 Single Dose Vials (Benadryl 01)
* Please review the disclaimer below.
