Otc - Active Ingredient
Active Ingredients (in each tablet):
Acetaminophen 325mg
Phenylephrine HCl 5mg
Chlorpheniramine Maleate 2mg
The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Relief-pe (NDC 50332-0153). 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/pharmacist, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients (in each tablet):
Acetaminophen 325mg
Phenylephrine HCl 5mg
Chlorpheniramine Maleate 2mg
Purpose:
Pain Reliever/Fever Reducer
Antihistamine
Nasal Decongestant
Temporarily relieves nasal congestion, sinus pressure, and minor aches and pains due to:
Temporarily reduces fever
Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
Do not use:
Ask a doctor or pharmacist before use if
Ask a doctor before use if you have
When using this product to not use more than directed. This product may cause excitability or drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Use caution when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if
These could be signs of serious condition
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.
Directions: Do not take more than directed. Adults and children 12 years of age an over:
Children under 12 years of age: ask a doctor
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelantined starch, stearic acid
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