国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
FRED'S, INC.
ORAL
OTC DRUG
Pain reliever/fever reducer Nasal decongestant - temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure - minor aches and pains - headache - nasal congestion - sinus congestion and pressure - helps decongest sinus openings and passages - promotes sinus drainage - helps clear nasal passages - temporarily reduces fever
OTC monograph final
SINUS AND HEADACHE DAYTIME NON-DROWSY- ACETAMINOPHEN AND PHENYLEPHRINE HCL TABLET, FILM COATED FRED'S, 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._ ---------- FREDS PHARMACY 44-466C _ACTIVE INGREDIENTS (IN EACH CAPLET)_ Acetaminophen 325 mg Phenylephrine HCl 5 mg _PURPOSE_ Pain reliever/fever reducer Nasal decongestant _USES_ temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever _WARNINGS_ LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount 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: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. 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 reaction to this product or any of its ingredients ASK A DOCTOR BEFORE USE IF YOU HAVE liver disease difficulty in urination due to enlargement of the prostate gland heart disease diabetes thyroid disease high blood pressure ASK A DOCTOR 阅读完整的文件