{
"meta": {
"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": "2026-10-05",
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{
"spl_product_data_elements": [
"Mucus Relief DM Honey and Berry Flavor Dextromethorphan Hydrobromide and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN anhydrous citric acid edetate disodium propylene glycol water sodium benzoate sorbitol sucralose xanthan gum"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients (in each 20 mL) Purposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Uses ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ▪ temporarily relieves: ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ▪ the intensity of coughing ▪ the impulse to cough to help you get to sleep"
],
"warnings": [
"Warnings Do not use ▪ 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. Ask a doctor before use if you have ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ▪ cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if ▪ cough lasts more than 7 days, comes back, or occurs with fever, 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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222."
],
"do_not_use": [
"Do not use ▪ 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."
],
"ask_doctor": [
"Ask a doctor before use if you have ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ▪ cough that occurs with too much phlegm (mucus)"
],
"when_using": [
"When using this product do not use more than directed"
],
"stop_use": [
"Stop use and ask a doctor if ▪ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs 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 ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor ▪ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours ▪ children under 12 years of age: do not use"
],
"storage_and_handling": [
"Other information ▪ each 20 mL contains : sodium 8 mg ▪ store at room temperature ▪ do not refrigerate"
],
"inactive_ingredient": [
"Inactive ingredients citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"
],
"questions": [
"Questions? 1-866-467-2748"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label *Compare to the active ingredient in Maximum Strength Mucinex® Fast Max® DM Max Honey & Berry Flavor NDC 68163-605-06 DRx Choice maximum Strength Mucus relief DM Dextromethorphan HBr – Cough Suppressant Guaifenesin – Expectorant • Controls Cough • Relieves Chest Congestion • Thins & Loosens Mucus • 4 Hour Dosing Honey& Berry Flavor Naturally and Artificially Flavored For Ages 12+ 6 FL OZ (180mL) Manufactured by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816 *This product is not manufactured or distributed by RB Health (US) the distributor of Maximum Strength Mucinex® Fast-Max® DM Max Honey & Berry Flavor DRx Choice Mucus Relief DM"
],
"set_id": "4898b1c2-55ef-4589-982b-2279c01707e5",
"id": "d9761c5f-9318-4c01-8744-836f610c3e22",
"effective_time": "20260908",
"version": "4",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"Mucus Relief DM Honey and Berry Flavor"
],
"generic_name": [
"DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN"
],
"manufacturer_name": [
"RARITAN PHARMACEUTICALS INC"
],
"product_ndc": [
"68163-605"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"DEXTROMETHORPHAN HYDROBROMIDE",
"GUAIFENESIN"
],
"rxcui": [
"1020138"
],
"spl_id": [
"d9761c5f-9318-4c01-8744-836f610c3e22"
],
"spl_set_id": [
"4898b1c2-55ef-4589-982b-2279c01707e5"
],
"package_ndc": [
"68163-605-06"
],
"is_original_packager": [
true
],
"nui": [
"N0000193956",
"N0000008867",
"N0000009560"
],
"pharm_class_epc": [
"Expectorant [EPC]"
],
"pharm_class_pe": [
"Decreased Respiratory Secretion Viscosity [PE]",
"Increased Respiratory Secretions [PE]"
],
"unii": [
"9D2RTI9KYH",
"495W7451VQ"
]
}
}
]
}