{"active_ingredient":["Active ingredient (in each 5 mL Cup) Guaifenesin 100 mg (in each 10 mL Cup) Guaifenesin 200 mg (in each 15 mL Cup) Guaifenesin 300 mg"],"ask_doctor":["Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"dosage_and_administration":["Directions Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. Age (yr) Dose (ml) adults and children 12 years and over 10 to 20 ml (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 ml (1 to 2 teaspoonfuls) every 4 hours children 2 years to under 6 years 2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours children under 2 years consult a physician Other Information Each 5 ml contains: sodium 4 mg. Each 10 ml contains: sodium 8 mg. Each 15 ml contains: sodium 12 mg. Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN. Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms: 5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17 10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56 15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16"],"dosage_and_administration_table":["
Age (yr)Dose (ml)
adults and children 12 years and over10 to 20 ml (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years5 to 10 ml (1 to 2 teaspoonfuls) every 4 hours
children 2 years to under 6 years2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours
children under 2 yearsconsult a physician
"],"effective_time":"20241017","id":"24b1b6f4-c113-8adc-e063-6394a90a546c","inactive_ingredient":["Inactive Ingredients Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate, and sodium citrate."],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive"],"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 ."],"openfda":{"application_number":["M012"],"brand_name":["Guaifenesin"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["American Health Packaging"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["60687-852-40","60687-852-46","60687-852-17","60687-863-42","60687-863-48","60687-863-56","60687-874-44","60687-874-50","60687-874-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["60687-852","60687-863","60687-874"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310604"],"spl_id":["24b1b6f4-c113-8adc-e063-6394a90a546c"],"spl_set_id":["2fd702ea-3069-472c-b99e-c527f1375705"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"other_safety_information":["Other Information Each 5 ml contains: sodium 4 mg. Each 10 ml contains: sodium 8 mg. Each 15 ml contains: sodium 12 mg. Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN. Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms: 5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17 10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56 15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16"],"package_label_principal_display_panel":["Package/Label Principal Display Panel – 100 mg per 5 mL – Label Case NDC 60687- 852 -17/Cup NDC 60687- 852 -40 Guaifenesin Oral Solution USP Expectorant 100 mg per 5 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C050624 R0624 100 mg per 5 mL Guaifenesin Oral Solution Label","Package/Label Principal Display Panel – 100 mg per 5 mL – Cup Lid NDC 60687- 852 -40 Guaifenesin Oral Solution, USP Expectorant 100 mg per 5 ml Sugar Free/Alcohol Free Delivers 5 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C050624 100 mg per 5 mL Guaifenesin Oral Solution Cup Lid","Package/Label Principal Display Panel – 200 mg per 10 mL – Label Case NDC 60687- 863 -56/Cup NDC 60687- 863 -42 Guaifenesin Oral Solution USP Expectorant 200 mg per 10 ml Sodium Content: 8 mg/10 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C100624 R0624 200 mg per 5 mL Guaifenesin Oral Solution Label","Package/Label Principal Display Panel – 200 mg per 10 mL – Cup Lid NDC 60687- 863 -42 Guaifenesin Oral Solution, USP Expectorant 200 mg per 10 ml Sodium Content: 8 mg/10 ml Sugar Free/Alcohol Free Delivers 10 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C100624 200 mg per 5 mL Guaifenesin Oral Solution Cup Lid","Package/Label Principal Display Panel – 300 mg per 15 mL – Label Case NDC 60687- 874 -16/Cup NDC 60687- 874 -44 Guaifenesin Oral Solution USP Expectorant 300 mg per 15 ml Sodium Content: 12 mg/15 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C150624 R0624 300 mg per 5 mL Guaifenesin Oral Solution Label","Package/Label Principal Display Panel – 300 mg per 15 mL – Cup Lid NDC 60687- 874 -44 Guaifenesin Oral Solution, USP Expectorant 300 mg per 15 ml Sodium Content: 12 mg/15 ml Sugar Free/Alcohol Free Delivers 15 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C150624 300 mg per 5 mL Guaifenesin Oral Solution Cup Lid"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant"],"questions":["Questions or comments? Call 1-800-845-8210"],"set_id":"2fd702ea-3069-472c-b99e-c527f1375705","spl_product_data_elements":["Guaifenesin Guaifenesin ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM ANHYDROUS CITRIC ACID GUAIFENESIN GUAIFENESIN Guaifenesin Guaifenesin ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM GUAIFENESIN GUAIFENESIN Guaifenesin Guaifenesin ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM GUAIFENESIN GUAIFENESIN"],"spl_unclassified_section":["Expectorant SUGAR FREE / ALCOHOL FREE","Generic Section Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). Distributed by: American Health Packaging Columbus, OH 43217 R0624"],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. you are hypersensitive to any of the ingredients."],"version":"1","warnings":["Warnings Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that 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. These could be signs of a serious condition. you are hypersensitive to any of the ingredients. 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 ."]}