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 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
temporarily relieves common cold/flu symptoms:
- •nasal congestion
- •sinus congestion and pressure
- •cough due to minor throat and bronchial irritation
- •minor aches and pains
- •sore throat
- •reduces swelling of nasal passages
- •temporarily restores freer breathing through the nose
- •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
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- •adult takes more than 4,000 mg of acetaminophen in 24 hours
- •child takes more than 5 doses in 24 hours
- •taken with other drugs containing acetaminophen
- •adult has 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
- •heart disease
- •thyroid disease
- •high blood pressure
- •trouble urinating due to an enlarged prostate gland
- •cough that occurs with too much phlegm (mucus)
- •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product
do not use more than directed
Stop Use And Ask A Doctor If
- •you get nervous, dizzy or sleepless
- •pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- •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 4 hrs
children 6 to under 12 yrs
15 mL every 4 hrs
children 4 to under 6 yrs
ask a doctor
children under 4 yrs
do not use
- •each 15 mL contains: sodium 6 mg
- •store at 20-25°C (68-77°F). Do not refrigerate.
butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Package/Label Principal Display Panel
Compare to Vicks® DayQuil® Severe active ingredients
Daytime Severe Cold & Flu
Pain Reliever/Fever Reducer
12 FL OZ (355 mL)
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