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"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-10-02",
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{
"spl_product_data_elements": [
"CVS Adult Mucus chest congestion Guaifenesin GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM Naturally and Artificially"
],
"active_ingredient": [
"Active ingredient (in each 10 mL) Guaifenesin, USP 200 mg"
],
"purpose": [
"Purpose Expectorant"
],
"indications_and_usage": [
"Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive"
],
"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 last for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. 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 at (1-800-222-1222)."
],
"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"
],
"stop_use": [
"Stop use and ask a doctor if cough last for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition."
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding, ask a health professional before use."
],
"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 at (1-800-222-1222)."
],
"dosage_and_administration": [
"Directions ▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter ▪ this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 ml – 20 ml every 4 hours children under 12 years do not use"
],
"dosage_and_administration_table": [
"
age
dose
adults and children 12 years and over
10 ml – 20 ml every 4 hours
children under 12 years
do not use
"
],
"storage_and_handling": [
"Other information • each 10 mL contains: sodium 4 mg • store at room temperature"
],
"inactive_ingredient": [
"Inactive ingredients anhydrous citric acid, disodium edetate, FD&C red no. 40, flavor, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum."
],
"package_label_principal_display_panel": [
"Principal Display Panel NDC# 51316-743-08 Compare to the active ingredient in Adult Robitussin Mucus + Chest Congestion* Adult Mucus+Chest Congestion Guaifenesin (Expectorant) Relieves: • Mucus • Chest congestion Sugar-Free No Added Alcohol Use Dosage Cup Included Natural Cherry Flavor For Ages 12 & Over 8 FL OZ (237 mL) IMPORTANT: Keep this carton for future reference on full labeling. *This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Adult Robitussin Mucus + Chest Congestion. CVS Adult Cough Syrup Cherry Flavor"
],
"package_label_principal_display_panel_table": [
"
IMPORTANT: Keep this carton for future reference on full labeling.