Otc - Active Ingredient
Active ingredients (in each caplet)
Diphenhydramine HCl 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods Llc for the product Complete Allergy Relief (NDC 67091-381). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• itchy, watery eyes
• sneezing
• itchy 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
Ask a doctor before use if you have
• glaucoma
• trouble urinating due to enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
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
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machinery
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.
Directions
• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours
adults and children 12 years of age and over: 1 to 2 caplets
children 6 to under 12 years of age: 1 caplet
children under 6 years of age: do not use this product in children under 6 years of age
Other information
•
each caplet contains: calcium 25 mg
• protect from light
• store at 25°C (77° F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package
Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide
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