The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredeints in each softgelACETAMINOPHEN 325 mgDextromethorphan Hydrobromide 10 mgDoxylamine Succinate 6.25 mgPhenylephrine HCl 5 mg
Inactive ingredients: FD&C Blue #1,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, , sorbitol sorbitan solution, titanium dioxide
Otc - Purpose
PURPOSEPain Reliever-Fever ReducerCough SuppressantAntihistamineNasal Decongestant
Indications & Usage
INDICATIONS & USAGEUses· temporarily relieves these symptoms due to a cold or flu:· minor aches and pains · headache · cough· sore throat · nasal and sinus congestion· temporarily reduces fever
Dosage & Administration
Directions· do not take more than the recommended dose· adults and children 12 years and over: take 2 capsules with waterevery 4 hours. Do not exceed 10 capsules in 24 hours or asdirected by a doctor.· children under 12 years: do not use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
WarningsLiver 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 aloholic drinks every day while using this productl Allergy alert: Acetaminophen may cause severe skin or severeallergic reactions. Symptoms may include:· skin reddening · blisters · rash · hives· facial swelling · asthma (wheezing) · shockIf a skin or general allergic reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than2 days, is accompanied or followed by fever, headache, rash, nausea,or vomiting, consult a doctor promptly.
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