{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["Directions • take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["<table width=\"30%\"><tbody><tr><td styleCode=\"Lrule Rrule Botrule\"> adults &amp; children<paragraph> 12 yrs &amp; over</paragraph></td><td styleCode=\"Rrule Botrule\"> 2 softgels with water<paragraph> every 4 hours</paragraph></td></tr><tr><td styleCode=\"Lrule Rrule Botrule\"> children 4 to under<paragraph> 12 yrs</paragraph></td><td styleCode=\"Rrule Botrule\" valign=\"top\"> ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule Botrule\"> children under 4 yrs</td><td styleCode=\"Rrule Botrule\"> do not use</td></tr></tbody></table>"],"effective_time":"20230808","id":"ada163e1-58ca-44a9-a3ee-5ba7edae9e53","inactive_ingredient":["Inactive ingredients edible printing ink, FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • minor aches & pains • headache • fever • 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."],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Packaging DG Health-285"],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? Call 1-888-577-8033 Monday - Friday 8am - 4pm EST"],"set_id":"91a66db7-ec48-4e62-bb5f-d6d6ddaf4cbe","spl_product_data_elements":["DG Health DayTime SEVERE Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SORBITAN oblong 811"],"spl_unclassified_section":["Drug Facts","COMPARE TO VICKS ® DAYQUIL ® SEVERE COLD & FLU ACTIVE INGREDIENTS* MULTI-SYMPTOM RELIEF • Chest Congestion, Thins and Loosens Mucus Antihistamine Free KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks ® and DayQuil™. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. Distributed by: Strive Pharmaceuticals Inc. East Brunswick, NJ 08816 Product of United Arab Emirates"],"storage_and_handling":["Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture"],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 softgels in 24 hours, which is the maximum daily amount for this product • 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 • 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. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to enlarged prostate gland • a sodium-restricted diet • 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; taking sedatives or tranquilizers. 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 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. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away."]}