Active Ingredient (In Each Tablet)
Diphenhydramine HCl 12.5 mg
Childrens Allergy Relief Tablet, Chewable
FDA Label NDC 59779-869
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 59779-869). 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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- 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
- take every 4 to 6 hours
- dissolve in mouth or chew before swallowing
- do not take more than 6 doses in 24 hours
children under 2 years | do not use |
children 2 to under 6 years | do not use unless directed by a doctor |
children 6 to under 12 years | 1 to 2 tablets |
adults and children 12 years and over | 2 to 4 tablets |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- 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
corn starch, dextrates hydrated, ethylcellulose, flavor, hydroxypropylcellulose, magnesium stearate, maltodextrin, mannitol, stearic acid, sucralose, triacetin
Questions Or Comments?
1-800-426-9391
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♥CVS Health™
Dye-Free Rapid Melt
NDC 59779-869-44
Children's
Allergy Relief
DIPHENHYDRAMINE HYDROCHLORIDE,
12.5 mg - Antihistamine
Relief of:
• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat
18 DISSOLVING TABLETS
RAPID MELT
Actual Size
Bubble Gum Flavored
Child-Resistant Packaging
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT
IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
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