Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
RB Health (US) LLC
ACETAMINOPHEN
ACETAMINOPHEN 325 mg
ORAL
OTC DRUG
- temporarily relieves these common cold and flu symptoms: nasal congestion fever headache minor aches and pains sinus congestion and pressure - nasal congestion - fever - headache - minor aches and pains - sinus congestion and pressure - temporarily promotes nasal and/or sinus drainage - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
OTC monograph final
MUCINEX FAST-MAX CONGESTION AND HEADACHE- ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED RB HEALTH (US) LLC _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._ ---------- MUCINEX® FAST-MAX CONGESTION & HEADACHE _DRUG FACTS_ _ACTIVE INGREDIENTS_ _(IN EACH CAPLET)_ _PURPOSES_ ACETAMINOPHEN 325 MG PAIN RELIEVER/FEVER REDUCER Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant USES temporarily relieves these common cold and flu symptoms: nasal congestion fever headache minor aches and pains sinus congestion and pressure temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive WARNINGS LIVER WARNING This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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. 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 diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland pe Read the complete document