- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredientingredients (in each caplet)
- Other information
- Inactive Ingredients
- Questions or comments?
- Principal Display Panel
FULL PRESCRIBING INFORMATION
Active ingredientingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
•for the temporary relief of the following cold/flu symptoms:
•minor aches and pains
•impulse to cough
•helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
•temporarily reduces fever
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
•more than 12 caplet4,000 mg of acetaminophen in 24 hours
•with other drugs containing acetaminophen
•3 or more alcoholic drinks every day while using this product
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
•high blood pressure
•trouble urinating due to an enlarged prostate gland
•cough that lastspersistent or is chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
•cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
When using this product
do not exceed recommended dosage
•nervousness, dizziness or sleeplessness occur
•pain, nasal congestion 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.
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.
do not take more than directed (see Liver warning)
adults and children 12 years and over
children under 12 years
ask a doctor
•each caplet contains: sodium 3 mg
•store at 20-25ºC (68-77ºF)
acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Questions or comments?
Principal Display Panel
INSTANT COOLING SENSATION
COMPARE TO active ingredients of TYLENOL® COLD MULTI-SYMPTOM SEVERE COOL BURST®
*See end panel
SEE NEW WARNINGS INFORMATIONAND DIRECTIONS
Pain Reliever/Fever Reducer/Nasal Decongestant/
Fever, Headache, SoreThroatSore Throat
Nasal Congestion, Coughing
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED