Active Ingredient(S)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Cold Medicine (NDC 69168-004). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
temporarily relieves
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:
psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.
If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this
product
sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
you have
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical
help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
corn starch, crospovidone, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
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