Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25mg
Allergy Relief Tablet
FDA Label NDC 84324-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Allergy Relief (NDC 84324-004). 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:, warnings:, directions, other information, inactive ingredients, questions or comments?, 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
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Warnings:
DO NOT USE:
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Directions
■ Take every 4 to 6 hours, or as directed by a doctor
■ do not take more than 6 times in 24 hours.
■ Adults and children 12 years and over: 1 to 2 tablets
■ Children 6 years to under 12 years: 1 tablet
■ Children under 6 years: Do not use
Other Information
Each tablet contains: ■Calcium 24mg ■Store between 20°-25°C (68°-77°F). Avoid high humidity. Protect from moisture and light.
Inactive Ingredients
Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Opadry-II 85G540006 Pink
Questions Or Comments?
Call 1 (718) 337-8733 or visit: [email protected]
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