Active Ingredients
Acetaminophen 500mg
Chlorpheniramine Maleate 4mg
Phenylephrine HCl 10mg
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl (NDC 69729-222). 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 ingredients, purpose, uses, liver warning:, allergy alert:, sore throat warning:, do not use, ask a doctor or pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500mg
Chlorpheniramine Maleate 4mg
Phenylephrine HCl 10mg
| Active Ingredients (in each caplet) | Purpose |
| Acetaminophen 500 mg | Pain reliever |
| Chlorpheniramine Maleate 4 mg | Antihistamine |
| Phenylephrine HCl 10 mg | Nasal descongestant |
Temporarily relieves these symptoms of hay fever or other respiratory allergies:
Temporarily relieves these additional symptoms of hay fever:
This product contains acetaminophen. Severe liver damage may occur if you take :
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen,
These could be signs of a serious condition.
ask a health professional before use.
Keep out of reach of children.
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Adults and children 12 years of age & over | 1 tablet with water every 4-6 hours as needed |
| Children 4 to 12 years of age | Ask a doctor |
| Children under 4 years of age | Do not use |
magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
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