FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Pain reliever/fever reducer
temporarily relieves common cold/flu symptoms:
- •cough due to minor throat and bronchial irritation
- •sore throat
- •minor aches and pains
- •runny nose and sneezing
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 product
Allergy alert: Acetaminophen 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 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.
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
- •cough that occurs with too much phlegm (mucus)
- •a breathing problem such as emphysema or chronic bronchitis
- •trouble urinating due to an enlarged prostate gland
- •persistent or chronic cough as occurs with smoking, asthma, or emphysema
- •a sodium-restricted diet
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
- •marked drowsiness may occur
- •avoid alcoholic drinks
- •be careful when driving a motor vehicle or operating machinery
- •alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- •pain or cough gets worse or lasts more than 7 days
- •fever gets worse or lasts more than 3 days
- •redness or swelling is present
- •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
- •only use the dose cup provided
- •do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over
30 mL every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
- •each 30 mL contains: sodium 39 mg
- •store at 20-25°C (68-77°F)
alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Package/Label Principal Display Panel
compare to Vicks® NyQuil® active ingredients
cold & flu relief
acetaminophen (pain reliever/fever reducer)
dextromethorphan HBr (cough suppressant)
doxylamine succinate (antihistamine)
powerful nighttime relief
aches & fever
12 FL OZ (355mL)
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