Active Ingredient
 Diphenhydramine HCl 25mg
Careall Allergy Relief Tablet, Coated
FDA Label NDC 51824-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Allergy Relief (NDC 51824-102). 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, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat
Warnings
Do not use
with any other products containing diphenhydramine, including ones used on skin
to make children sleepy
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 beverages
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
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 of age and older: 1 to 2 caplets
Children 6 to 12 years: 1 caplet
Children under 6: do not use
Inactive Ingredients
croscarmellose sodium, D C Red 27 aluminum lake, hypromellose, lactose, magnesium stearate, microcystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
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