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.
Active Ingredients (In Each Softgel)
Acetaminophen 325 mgDextromethorphan HBr 15 mgDoxylamine succinate 6.25 mg
Pain reliever/fever reducerCough suppressantAntihistamine
- Temporarily relieves common cold/flu symptoms: •cough due to minor throat and bronchial irritation •minor aches and pains •runny nose and sneezing •sore throat •headache •fever
- Liver 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 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 product. •if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
- •liver disease •glaucoma •cough that occurs with too much phlegm (mucus) •a breathing problem such as emphysema or chronic bronchitis •persistent or chronic cough as occurs with smoking, asthma, or emphysema •trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- •taking sedatives or tranquilizers •taking the blood thinning drug warfarin
When Using This Product
- •excitability may occur, especially in children •be careful when driving a motor vehicle or operating machinery •avoid alcoholic drinks •alcohol, sedatives, and tranquilizers may increase drowsiness •marked drowsiness may occur
Stop Use And Ask A Doctor If
- •pain or cough gets worse or lasts more than 7 days •redness or swelling is present •fever gets worse or lasts more than 3 days •new symptoms occur •cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
Ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: 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.
- •take only as directed – see overdose warning •do not exceed 4 doses per 24 hoursadults & children 12 yrs & over2 softgels with water every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use
D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
* Please review the disclaimer below.