{"active_ingredient":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL Active ingredients (in each 5 mL unit) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg"],"dosage_and_administration":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL unit vial/ampoule Directions do not take more than 6 doses in any 24-hour period mL = milliliter Age (year) Dose (mL) (Children under 4 do not use) 4 to under 6 years 1 single-use vial (5 mL each) every 4 hours 6 to under 12 years 2 single-use vial (5 mL each) every 4 hours Adults and children 12 years & older 4 single-use vial (5 mL each) every 4 hours"],"dosage_and_administration_table":["
Age (year)
Dose (mL)
(Children under 4 do not use)
4 to under 6 years
1 single-use vial (5 mL each) every 4 hours
6 to under 12 years
2 single-use vial (5 mL each) every 4 hours
Adults and children 12 years & older
4 single-use vial (5 mL each) every 4 hours
"],"effective_time":"20220923","id":"e95f0c2d-9102-7494-e053-2995a90a7ac5","inactive_ingredient":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL Inactive ingredients cherry flavor, citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, sucralose, xanthan gum"],"indications_and_usage":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes"],"keep_out_of_reach_of_children":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"openfda":{},"other_safety_information":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL Other information each 5 mL contains: sodium 3 mg store at 20-25°C (68-77°F). Do not Refrigerate. sugar free, dye free, alcohol free see end of unit/foil pouch for lot number and expiration date"],"package_label_principal_display_panel":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL 12 Ampoules Single Use Measurements, for easy accurate dosing *COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S ROBITUSSIN® COUGH & CHEST CONGESTION DM CORRECT DOSE® Precise - Portable - Single-Use non-drowsy Children's COUGH & CHEST CONGESTION DM Detromethorphan HBr 5mg Guaifenesin 100mg for ages 4 and over Cherry 12 PRE-FILLED SINGLE-USE DOSES RELIEVES: CHEST CONGESTION & STUFFY NOSE BREAKS UP MUCUS CONTROLS COUGH 2.04 FL. OZ (60 mL) 12 - 5 mL INDIVIDUAL DOSES Cough and Chest Congestion 12-count Pouch Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL unit vial/ampoule Directions do not take more than 6 doses in any 24-hour period mL = milliliter Age (year) Dose (mL) (Children under 4 do not use) 4 to under 6 years 1 single-use vial (5 mL each) every 4 hours 6 to under 12 years 2 single-use vial (5 mL each) every 4 hours Adults and children 12 years & older 4 single-use vial (5 mL each) every 4 hours Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL Warnings Do not use if your child is 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 cough occurs with too much phlegm (mucus) cough lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema ___________________________________________________________________ Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. This could be signs of a serious condition. _________________________________________________________________ If pregant or breast-feeding, ask a health professional before use. Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL Inactive ingredients cherry flavor, citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, sucralose, xanthan gum Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL Active ingredients (in each 5 mL unit) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL Purpose Cough Suppressant Expectorant Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL Other information each 5 mL contains: sodium 3 mg store at 20-25°C (68-77°F). Do not Refrigerate. sugar free, dye free, alcohol free see end of unit/foil pouch for lot number and expiration date Individual Pouch Principal Display Panel CorrectDose® Precise - Portable - Single-Use Non-Drowsy Children's Cough & Chest Congestion DM Dextromethorphan HBr 5mg Guaifenesin 100mg for ages 4 and over Cherry 1 Pre-Filled Single-Use Dose LASTS UP TO 4 HOURS WARNING: CHOKING HAZARD - SMALL PARTS. KEEP OUT OF REACH OF SMALL CHILDREN. 0.17 FL. OZ (5 mL) Cough and Chest Congestion - Individual Pouch","Individual Pouch Principal Display Panel CorrectDose® Precise - Portable - Single-Use Non-Drowsy Children's Cough & Chest Congestion DM Dextromethorphan HBr 5mg Guaifenesin 100mg for ages 4 and over Cherry 1 Pre-Filled Single-Use Dose LASTS UP TO 4 HOURS WARNING: CHOKING HAZARD - SMALL PARTS. KEEP OUT OF REACH OF SMALL CHILDREN. 0.17 FL. OZ (5 mL) Cough and Chest Congestion - Individual Pouch"],"package_label_principal_display_panel_table":["
Age (year)
Dose (mL)
(Children under 4 do not use)
4 to under 6 years
1 single-use vial (5 mL each) every 4 hours
6 to under 12 years
2 single-use vial (5 mL each) every 4 hours
Adults and children 12 years & older
4 single-use vial (5 mL each) every 4 hours
"],"purpose":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL Purpose Cough Suppressant Expectorant"],"set_id":"c0e11ee5-f9d0-44a1-e053-2995a90a5c2f","spl_product_data_elements":["Cough and Chest Congestion DM Guaifenesin Dextromethorphan hydrobromide Oral Solution SUCRALOSE XANTHAN GUM GLYCERIN ANHYDROUS CITRIC ACID PROPYLENE GLYCOL SACCHARIN SODIUM SACCHARIN SORBITOL SODIUM BENZOATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN"],"version":"3","warnings":["Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL Warnings Do not use if your child is 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 cough occurs with too much phlegm (mucus) cough lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema ___________________________________________________________________ Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. This could be signs of a serious condition. _________________________________________________________________ If pregant or breast-feeding, ask a health professional before use."]}