Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 12.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Childrens Chewable Allergy Relief (NDC 41226-669). 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 chewable tablet), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Diphenhydramine HCl 12.5 mg
Antihistamine
-runny nose
-sneezing
-itchy, watery eyes
-itching of the nose or throat
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
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 right away (1-800-222-1222).
| Age (years) | Dose (chewable tablets) |
| 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 chewable tablets (12.5 mg to 25 mg) |
| adults and children 12 years and over | 2 to 4 chewable tablets (25 mg to 50 mg) |
acacia, crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7, dextrose monohydrate, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sucralose, sucrose, tartaric acid
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