Country: United States
Language: English
Source: 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)
AAA Pharmaceutical, Inc.
ORAL
OTC DRUG
- temporarily relieves these symptoms of the common cold: runny nose sneezing headache sore throat minor aches and pains nasal congestion cough - runny nose - sneezing - headache - sore throat - minor aches and pains - nasal congestion - cough - temporarily reduces fever
OTC monograph final
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED AAA PHARMACEUTICAL, 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._ ---------- ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL TABLETS -1124 _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH CAPLET)_ _PURPOSE_ Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant US ES temporarily relieves these symptoms of the common cold: runny nose sneezing headache sore throat minor aches and pains nasal congestion cough temporarily reduces fever 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 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 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. ASK A DOCTOR BEFORE USE IF YOU HAVE liver disease diabetes heart disease high blood pressure thyroid disease glaucoma trouble urinating due to an enla Read the complete document