{"active_ingredient":["ACTIVE INGREDIENTS (IN EACH 30 ML) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg"],"dosage_and_administration":["DIRECTIONS Take only as directed - see Overdose warning Use dose cup Do not exceed 4 doses per 24 hrs Adults & children 12 yrs & over 30 mL every 6 hrs Children 4 to under 12 yrs Ask a doctor Children under 4 yrs Do not use"],"dosage_and_administration_table":["<table width=\"50%\"><caption/><tbody><tr><td> Adults &amp; children 12 yrs &amp; over</td><td> 30 mL every 6 hrs </td></tr><tr><td> Children 4 to under 12 yrs</td><td> Ask a doctor</td></tr><tr><td> Children under 4 yrs</td><td> Do not use</td></tr></tbody></table>"],"effective_time":"20230208","id":"f42c0ea8-6241-bccf-e053-2995a90aa314","inactive_ingredient":["INACTIVE INGREDIENTS Alcohol, Anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, Flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Purified water, Saccharin sodium, Sodium citrate"],"indications_and_usage":["USES Temporarily relieves common cold/flu symptoms: • Cough due to minor throat and bronchial irritation • Sore throat • Headache • Minor aches and pains • Fever • Runny nose and sneezing"],"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. Quick medical attention is critical for adults as well as or children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Packaging coldflu028"],"purpose":["PURPOSE Pain reliever / Fever reducer Cough suppressant Antihistamine"],"questions":["QUESTIONS OR COMMENTS? Call toll-free 1-800-572-6632, weekdays, 7:00 AM - 5:30 PM EST."],"set_id":"a648ccf0-9b28-482e-b541-173bd0b52c79","spl_product_data_elements":["L-Oral COLD AND FLU RELIEF-DS Syrup Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate ALCOHOL ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C GREEN NO. 3 FD&C YELLOW NO. 6 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE"],"spl_unclassified_section":["DRUG FACTS","√ Cough Relief √ Aches √ Fever √ Sore throat √ Sneezing/Runny nose Manufactured by: Global Pharma Healthcare Pvt. Ltd., A-9, SIDCO Pharmaceutical Complex, Alathur-603 110 - INDIA. www.global-pharma.com"],"storage_and_handling":["OTHER INFORMATION • Each 30 mL contains: sodium 38 mg • Store at 20-25°C (68-77°F)"],"version":"2","warnings":["WARNINGS Liver warning: This product contains acetaminophen. 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 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. • 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 • Glaucoma • Cough that occurs with too much phlegm (mucus) • A breathing problem such as emphysema or chronic bronchitis • Trouble urinating due to an enlarged prostate gland • Persistent or chronic cough as occurs with smoking, asthma, or emphysema • A sodium-restricted diet Ask a doctor or pharmacist before use if you are • Taking sedatives or tranquilizers • Taking the blood thinning drug When using this product • Excitability may occur, especially in children • Marked drowsiness may occur • Avoid alcoholic drinks • Be careful when driving a motor vehicle or operating machinery • Alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • Pain 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. Quick medical attention is critical for adults as well as or children even if you do not notice any signs or symptoms."]}