Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Topco Associates LLC
ORAL
OTC DRUG
Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant
OTC monograph final
TOPCARE CHILDRENS COLD AND FLU- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE SUSPENSION TOPCO ASSOCIATES 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._ ---------- TOPCO ASSOCIATES LLC. CHILDREN’S COLD & FLU DRUG FACTS ACTIVE INGREDIENTS (IN EACH 5 ML) Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg PURPOS E Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant US ES • • • • • • • • WARNINGS LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if your child takes • • ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms may include: • • • temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough stuffy nose sneezing and runny nose temporarily reduces fever more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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 • • • • ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS • • • • • • • • • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS • • WHEN USING THIS PRODUCT • • • • STOP USE AND ASK A DOCTOR IF • • • • • • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotiona Soma hati kamili