Cold relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM CARNAUBA WAX CROSCARMELLOSE SODIUM CROSPOVIDONE (15 MPA.S AT 5%) MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE L234
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel Compare to Tylenol® Cold Head Congestion Severe active ingredients SEE NEW WARNINGS AND DIRECTIONS Cool Ice® Instant Cooling Sensation Cold Relief Head Congestion Severe Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant Headache / Sore Throat – Acetaminophen Nasal Congestion – Phenylephrine HCl Coughing – Dextromethorphan HBr Chest Congestion – Guaifenesin DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN Non-Drowsy DayTime Cold Relief Carton Image 1 Cold Relief Carton Image 2
- Principal Display Panel Compare to Tylenol® Cold Head Congestion Severe active ingredients SEE NEW WARNINGS AND DIRECTIONS Cool Ice® Instant Cooling Sensation Cold Relief Head Congestion Severe Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant Headache / Sore Throat – Acetaminophen Nasal Congestion – Phenylephrine HCl Coughing – Dextromethorphan HBr Chest Congestion – Guaifenesin DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN Non-Drowsy DayTime Cold Relief Carton Image 1 Cold Relief Carton Image 2
Overview
Uses • for the temporary relief of the following cold/flu symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • impulse to cough • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever
Indications & Usage
Uses • for the temporary relief of the following cold/flu symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • impulse to cough • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever
Dosage & Administration
Directions • do not take more than directed (see Liver warning) adults and children 12 years and over • take 2 caplets every 4 hours • swallow whole – do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
Warnings & Precautions
Warnings 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 4,000 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 • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or 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 Stop use and ask a doctor if • 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.
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Do Not Use
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
When Using
When using this product do not exceed recommended dosage
Stop Use & Ask a Doctor
Stop use and ask a doctor if • 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.
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.
Storage & Handling
Other information • each caplet contains: sodium 3 mg
Questions
Questions? 1-800-719-9260
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