FDA Label for Careall Diphenhydramine
View Indications, Usage & Precautions
Careall Diphenhydramine Product Label
The following document was submitted to the FDA by the labeler of this product New World Imports, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
 Diphenhydramine HCl 25mg
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
Temporarily relieves these symptoms associated with the common cold:
Sneezing, runny nose
Warnings
Do not use with any other products containing diphenhydramine, including ones 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 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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