Negara: Amerika Serikat
Bahasa: Inggris
Sumber: 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)
Grandall Distributing Co., Inc.
TOPICAL
OTC DRUG
• temporarily relieves the following cold/flu symptoms • minor aches and pains • sore throat • cough • sneezing and runny nose • headache • nasal congestion • stuffy nose • temporarily reduces fever
OTC monograph final
CALMADOL PLUS- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID GRANDALL DISTRIBUTING CO., 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._ ---------- CALMADOL PLUS _ACTIVE INGREDIENTS (IN EACH 5 ML)_ Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg _PURPOSES_ Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant _USES_ • temporarily relieves the following cold/flu symptoms • minor aches and pains • sore throat • cough • sneezing and runny nose • headache • nasal congestion • stuffy nose • temporarily reduces fever _WARNINGS_ LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if your child takes: • more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen 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. KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. _DIRECTIONS_ THIS PRODUCT DOES NOT CONTAIN DIRECTIONS OR COMPLETE WARNINGS FOR ADULT USE mL = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. ke Baca dokumen lengkapnya