Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
SuperValu Inc.
ACETAMINOPHEN
ACETAMINOPHEN 325 mg
ORAL
OTC DRUG
- temporarily relieves these common cold/flu symptoms: sinus congestion and pressure nasal congestion cough sore throat minor aches and pains headache - sinus congestion and pressure - nasal congestion - cough - sore throat - minor aches and pains - headache - promotes nasal and sinus drainage - temporarily reduces fever
OTC monograph final
PRESSURE AND PAIN PE PLUS COUGH- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED SUPERVALU INC. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- ELN - 1172 - 2016-0829 _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH_ _CAPLET)_ _PURPOSE_ Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant USES temporarily relieves these common cold/flu symptoms: sinus congestion and pressure nasal congestion cough sore throat minor aches and pains headache promotes nasal and sinus drainage temporarily reduces fever WARNINGS LIVER WARNING This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product ALLERGY ALERT acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. SORE THROAT WARNING If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. DO NOT USE with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, 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. if you have ever had an allergic react Read the complete document