DRISTAN COLD MULTISYMPTOM acetaminophen, chlorpheniramine maleate, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CALCIUM STEARATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN STEARIC ACID Upper Yellow Layer Bottom White Layer Round film-coated tablet d
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton See new warnings information Dristan ® Cold Acetaminophen➤➤Pain reliever/Fever reducer Chlorpheniramine maleate➤➤Antihistamine Phenylephrine HCl➤➤Nasal decongestant multi-symptom formula For relief of Nasal Congestion, Sinus Pressure, Headache, Aches and Pains, Fever, Runny Nose and Sneezing 20 COATED TABLETS PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
- PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton See new warnings information Dristan ® Cold Acetaminophen➤➤Pain reliever/Fever reducer Chlorpheniramine maleate➤➤Antihistamine Phenylephrine HCl➤➤Nasal decongestant multi-symptom formula For relief of Nasal Congestion, Sinus Pressure, Headache, Aches and Pains, Fever, Runny Nose and Sneezing 20 COATED TABLETS PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
Overview
Uses • temporarily relieves these symptoms associated with a cold, or flu: • headache • nasal congestion • sore throat • fever • minor aches and pains • temporarily relieves minor aches, pains and headache as well as these symptoms of hay fever or other upper respiratory allergies: • runny nose • sneezing • nasal congestion • itching of the nose or throat • itchy, watery eyes • temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages
Indications & Usage
Uses • temporarily relieves these symptoms associated with a cold, or flu: • headache • nasal congestion • sore throat • fever • minor aches and pains • temporarily relieves minor aches, pains and headache as well as these symptoms of hay fever or other upper respiratory allergies: • runny nose • sneezing • nasal congestion • itching of the nose or throat • itchy, watery eyes • temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages
Dosage & Administration
Directions • do not use more than 12 tablets in any 24-hour period • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 tablets every 4 hours children under 12 years do not use
Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take • more than 12 tablets in any 24-hour period, which is the maximum daily amount • 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 • blisters • rash 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 • to sedate a child or to make a child sleepy • 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. • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. 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 • glaucoma • a breathing problem such as emphysema, asthma, or chronic bronchitis Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking any other oral nasal decongestant or stimulant • taking any other pain reliever/fever reducer • taking sedatives or tranquilizers When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • pain or nasal congestion 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 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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Purpose
Purposes Pain reliever/Fever reducer Antihistamine Nasal decongestant
Do Not Use
Do not use • to sedate a child or to make a child sleepy • 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. • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
When Using
When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children
Stop Use & Ask a Doctor
Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • pain or nasal congestion 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
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. Prompt 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 • store at 20-25°C (68-77°F) • tamper-evident individual blisters
Questions
Questions or comments? Call weekdays from 9 AM to 5 PM EST at 1-800-535-0026 Made in Canada For most recent product information, visit www.dristan.com
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