País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
TopCare
ORAL
OTC DRUG
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing headache minor aches and pains nasal congestion sinus congestion and pressure itchy, watery eyes itching of the nose or throat - runny nose - sneezing - headache - minor aches and pains - nasal congestion - sinus congestion and pressure - itchy, watery eyes - itching of the nose or throat
OTC monograph final
SEVERE ALLERGY PLUS SINUS HEADACHE- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED TOPCARE _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._ ---------- TCR - 1126 - 2019-1007 _DRUG FACTS_ _ACTIVE INGREDIENTS _ _(IN EACH CAPLET)_ _PURPOSE_ Acetaminophen 325 mg Pain reliever Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant USES temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing headache minor aches and pains nasal congestion sinus congestion and pressure itchy, watery eyes itching of the nose or throat 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 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. 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. with any other product containing diphenhydramine, even one used on skin 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 heart disease high blood pressure thyroid disease diabetes glaucoma trouble u Leia o documento completo