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 tablet) Acetaminophen 325 mgDextromethorphan Hydrobromide 15 mgGuaifenesin 200 mg Phenylephrine Hydrochloride 5 mg .
Otc - Purpose
PurposePain reliever/ fever reducerCough suppressantExpectorantNasal decongestant
Indications & Usage
Uses■ for the temporary relief of the following cold/flu symptoms:■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive■ temporarily reduces fever
WarningsLiver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. 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 alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening■ blisters■ rashIf 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.
Otc - Do Not Use
Do not use■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
drug contains acetaminophen, ask a doctor or pharmacist.
■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If
you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this
■ if you have ever had an allergic reaction to this product or any of its ingredients■ for more than 10 days unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have■ liver disease■ heart disease■ high blood pressure■ thyroid disease■ diabetes■ trouble urinating due to an enlarged prostate gland■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema■ cough that occurs with too much phlegm (mucus)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose
Otc - Stop Use
Stop use and ask a doctor if■ nervousness, dizziness, or sleeplessness occur■ pain, nasal congestion or cough gets worse or lasts for more than 7 days■ fever gets worse or lasts for more than 3 days■ redness or swelling is present■ new symptoms occur■ cough comes back or occurs with rash or headache that lastsThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.Overdose warningIn 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.
Dosage & Administration
do not take more than directed (see overdose warning)Adults and children12 years and older■ take 2 tablets every 6-8 hours■ swallow whole; do not crush, chew or dissolve■ do not take more than 8 tablets in 24 hoursChildren under 12 yearsask a doctor
Other Safety Information
Other information■ store at room temperature 68º-77ºF (20º-25ºC)■ keep this product protected from extremes of moisture, heat and light■
Tamper Evident child resistant packets
■ do not use any opened or torn packets
Inactive ingredientsmaltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid
Otc - Questions
Questions or comments? 1-800-634-7680
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