Land: USA
Sprog: engelsk
Kilde: 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 COLD- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL 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 PAIN RELIEF PLUS MULTI-SYMPTOM COLD 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 ES 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 minor aches and pains headache minor sore throat pain runny nose itchy nose or throat sneezing itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen skin reddening • • 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 TAKING • • WHEN USING THIS PRODUCT • • • • STOP USE AND ASK A DOCTOR IF • • • • blisters rash in a child under 4 years of age if your child has ever had an allergic reaction to this product or any of its ingredients with any other drug containing acetaminophen (prescription or nonprescription) Læs hele dokumentet