Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
The Procter & Gamble Manufacturing Company
ORAL
OTC DRUG
- temporarily relieves symptoms due to the common cold minor aches and pains headache fever nasal congestion sinus congestion & pressure - minor aches and pains - headache - fever - nasal congestion - sinus congestion & pressure - temporarily relieves symptoms due to hay fever or other upper respiratory allergies minor aches and pains headache nasal congestion sinus congestion & pressure - minor aches and pains - headache - nasal congestion - sinus congestion & pressure
OTC monograph final
VICKS SINEX- ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED THE PROCTER & GAMBLE MANUFACTURING COMPANY _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._ ---------- VICKS SINEX™ DAYTIME CONGESTION, PRESSURE & PAIN _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH LIQUICAP)_ _PURPOSE_ Acetaminophen 325 mg Pain reliever/Fever reducer Phenylephrine HCl 5 mg Nasal decongestant US ES temporarily relieves symptoms due to the common cold minor aches and pains headache fever nasal congestion sinus congestion & pressure temporarily relieves symptoms due to hay fever or other upper respiratory allergies minor aches and pains headache nasal congestion sinus congestion & pressure WARNINGS LIVER WARNING This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. ASK A DOCTOR BEFORE USE IF YOU HAVE liver disease ® heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking the blood thinning drug warfarin. WHEN USING THIS PRODUCT, DO NOT USE MORE THAN DIRECTED. STOP USE AND ASK A DOCTOR IF pain or nasal congestion gets worse or lasts more than 7 days fever Read the complete document