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
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 15 mg
Doxylamine succinate 6.25 mg
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
- Usestemporarily relieves common cold/flu symptoms:cough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfeverrunny nose & sneezing
- WarningsLiver warning:
- This product contains acetaminophen. Severe liver damage may occur if you take:
- More than 8 softgels in 24 hrs, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks daily while using this productAllergy Alert:
- Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddeningBlistersRashIf 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 usewith 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 product.
Otc - Ask Doctor
- Ask a doctor before use if you haveliver diseaseheart diseasehigh blood pressurethyroid diseasediabetesglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysematrouble urinating due to enlarged prostate gland
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizerstaking the blood thinning drug warfarin
Otc - When Using
- When using this productdo not use more than directedexcitability may occur, especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful when driving a motor vehicle or operating machineryalcohol, sedatives, & tranquilizers may increase drowsiness
Otc - Stop Use
- Stop use and ask a doctor ifyou get nervous, dizzy or sleeplesspain, nasal congestion, or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lasts.These 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.
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.
Dosage & Administration
- Directionstake only as directeddo not exceed 4 doses per 24 hrsadults & children 12 yrs & over: 2 softgels with water every 6 hrs
- Children 4 to under 12 yrs: ask a doctor
- Children under 4 yrs: do not use
- Other informationstore at room temperature
Inactive ingredients FD&C Blue #1, D&C yellow #10,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water,shellac, sorbitol sorbitan solution,titanium dioxide.
Otc - Questions
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