{"active_ingredient":["ACTIVE INGREDIENT (IN EACH 5 ML) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["DIRECTIONS • Take only as directed - see Overdose warning • Only use the dose cup provided • Do not exceed 4 doses per 24 hrs Adults & children 12 yrs & over 30 mL every 4 hrs Children 6 to under 12 yrs 15 mL every 4 hrs Children 4 to under 6 yrs Ask a doctor Children under 4 yrs Do not use"],"dosage_and_administration_table":["<table width=\"40%\"><caption/><tbody><tr><td styleCode=\"Botrule Toprule\"> Adults &amp; children 12 yrs &amp; over</td><td styleCode=\"Botrule Toprule\"> 30 mL every 4 hrs</td></tr><tr><td styleCode=\"Botrule Toprule\"> Children 6 to under 12 yrs</td><td styleCode=\"Botrule Toprule\"> 15 mL every 4 hrs</td></tr><tr><td styleCode=\"Botrule Toprule\"> Children 4 to under 6 yrs</td><td styleCode=\"Botrule Toprule\"> Ask a doctor</td></tr><tr><td styleCode=\"Botrule Toprule\"> Children under 4 yrs </td><td styleCode=\"Botrule Toprule\"> Do not use</td></tr></tbody></table>"],"effective_time":"20230208","id":"f42bf796-2ffd-7224-e053-2995a90a7f5a","inactive_ingredient":["INACTIVE INGREDIENTS Butylated hydroxyanisole, Edetate disodium, FD&C yellow no. 6, Flavor, Glycerin, Menthol, Monobasic sodium phosphate, Polyethylene glycol, Propylene glycol, Purified water, Saccharin sodium, Sucrose, Xanthan gum"],"indications_and_usage":["USES • Temporarily relieves common cold/flu symptoms: • Nasal congestion • Cough due to minor throat and bronchial irritation • Sore throat • Headache • Minor aches and pains • Fever"],"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 for children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Packaging Loral27-5"],"purpose":["PURPOSE Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"questions":["QUESTIONS OR COMMENTS? Call toll-free 1-800-572-6632, weekdays, 7:00 AM - 5:30 PM EST."],"set_id":"d38cd1fb-7dec-4860-a73a-316c982a4c5b","spl_product_data_elements":["L-Oral COLD AND FLU RELIEF Syrup Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride BUTYLATED HYDROXYANISOLE EDETATE DISODIUM FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SACCHARIN SODIUM SUCROSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"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 15 mL contains: sodium 7 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 • Adult takes more than 4,000 mg of acetaminophen in 24 hours • Child takes more than 5 doses in 24 hours • Taken with other drugs containing acetaminophen • Adult has 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 • Heart disease • Thyroid disease • Diabetes • High blood pressure • Trouble urinating due to an enlarged prostate gland • Cough that occurs with too much phlegm (mucus) • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin 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 5 days (children) or 7 days (adults) • 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 for children even if you do not notice any signs or symptoms."]}