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 ingredients (in each softgel)acetamnophen 325 mg - Dextromethorphan HBr 10mg - Gualifenesin 200 mg - Phenylephrine HCl 5 mg
Inactive ingredients: FD&C yellow#6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Otc - Purpose
PURPOSEPain reliever/fever reducer
Indications & Usage
INDICATIONS & USAGE
temporarily relieves these common cold and flu symptoms: nasal congestion - headache - cough - minor aches and pains - sore throat - temporarily reduces fever - promotes nasal and/or sinus drainage - helps ...
temporarily relieves these common cold and flu symptoms:
minor aches and pains
temporarily reduces fever
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & Administration
DOSAGE & ADMINISTRATIONDirections
Do not take more than directed (see Overdose warning) do not take more than 12 SOFTGELS in any 24-hour period \
adults and children 12 years of age and over: take 2 SOFTGELS every 4 hours
children under 12 years of age: do not use
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
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 ...
Keep out of reach of children.Overdose warningTaking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take: more than 12softgels in 24 hours, which is the maximum daily amount - with other drugs ...
Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take:more than 12 softgels in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product
Allergy alertAcetaminophen may cause severe skin reactions. Symptoms may include:skin reddening
If a skin reaction occurs, stop use and seek medical help right away.Sore throat warningIf 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.
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