Active Ingredient (In Each Tablet)
Diphenhydramine HCl 12.5 mg
Childrens Allergy Relief Tablet, Chewable
FDA Label NDC 59779-585
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 for the product Childrens Allergy Relief (NDC 59779-585). 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 active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
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 You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- dissolve in mouth or chew before swallowing
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
| children under 2 years of age | do not use |
| children 2 to under 6 years of age | do not use unless |
| children 6 to under 12 years of age | 1 to 2 tablets |
adults and children 12 years | 2 to 4 tablets |
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose polymers, FD&C blue #1 aluminum lake, grape flavor art #554, magnesium stearate, mannitol, polyethylene and polypropylene polymers, stearic acid, sucralose
Questions Or Comments?
1-800-426-9391
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Compare to the active ingredient in
Children's Benadryl® Allergy FastMelt® Tablets*
Rapid Melt
NDC 59779-585-44
Children's
Allergy Relief
DIPHENHYDRAMINE
HYDROCHLORIDE,12.5 mg
Antihistamine
Relief of:
•Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat
18 DISSOLVING TABLETS
Actual Size
Grape Flavored
Child-Resistant Packaging
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Children's Benadryl® Allergy FastMelt® Tablets.
50844 REV0512A58544
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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Cvs 44-585 (Cvs 44 585 1)
* Please review the disclaimer below.
