{"active_ingredient":["Active ingredients (in each tablet) Acetaminophen, USP 325 mg Chlorpheniramine maleate, USP 2 mg Phenylephrine HCl, USP 5 mg"],"ask_doctor":["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_doctor_or_pharmacist":["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"],"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."],"dosage_and_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"],"dosage_and_administration_table":["
agedose
adults and children 12 years and over2 tablets every 4 hours
children under 12 yearsdo not use
"],"effective_time":"20210608","id":"03dd1415-1bef-4d8a-9024-81e26928773f","inactive_ingredient":["Inactive ingredients calcium stearate, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid"],"indications_and_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"],"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."],"openfda":{},"package_label_principal_display_panel":["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"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/Fever reducer Antihistamine Nasal decongestant"],"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"],"set_id":"a14515f3-197f-3d3e-1cf8-fc09925d1d88","spl_product_data_elements":["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"],"spl_unclassified_section":["Distributed by: Pfizer, Madison, NJ 07940 USA"],"stop_use":["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"],"storage_and_handling":["Other information • store at 20-25°C (68-77°F) • tamper-evident individual blisters"],"version":"12","warnings":["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."],"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"]}