מדינה: ארצות הברית
שפה: אנגלית
מקור: 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)
Fred's, Inc.
ACETAMINOPHEN
ACETAMINOPHEN 650 mg in 30 mL
ORAL
OTC DRUG
Pain Reliever/Fever Reducer Antihistamine/Cough suppressant Nasal decongestant - temporarily relieves these symptoms due to a cold: - minor aches and pains - minor sore throat pain - headache - nasal and sinus congestion - runny nose - sneezing - itchy nose or throat - itchy, watery eyes due to hay fever - cough due to minor throat and bronchial irritation - temporarily reduces fever - in a child under 12 years of age - if you are allergic to acetaminophen - 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 the 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 tak
OTC monograph final
NIGHT TIME SEVERE COLD AND COUGH - ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL SYRUP 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._ ---------- _DRUG FACTS_ _ACTIVE INGREDIENTS_ _(IN EACH 30 ML (2 TBSP))_ Acetaminophen, USP 650 mg Diphenhydramine HCl, USP 25 mg Phenylephrine HCl, USP 10 mg _PURPOSES_ Pain Reliever/Fever Reducer Antihistamine/Cough suppressant Nasal decongestant _USES_ temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever _WARNINGS_ LIVER WARNING: This product contains acetaminophen. 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 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. 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 in a child under 12 years of age if you are allergic to acetaminophen 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 the 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 prescrip קרא את המסמך השלם