max cold, flu, and sore throat

Generic: acetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl

Labeler: h e b
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name max cold, flu, and sore throat
Generic Name acetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl
Labeler h e b
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 400 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-316
Product ID 37808-316_0d19111b-d15e-4e5d-a9e1-5403e7509902
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2014-03-05

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808316
Hyphenated Format 37808-316

Supplemental Identifiers

RxCUI
1116572
UPC
0041220387014
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name max cold, flu, and sore throat (source: ndc)
Generic Name acetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 20 mg/20mL
  • 400 mg/20mL
  • 10 mg/20mL
source: ndc
Packaging
  • 117 mL in 1 BOTTLE (37808-316-25)
source: ndc

Packages (1)

Ingredients (4)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (400 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "0d19111b-d15e-4e5d-a9e1-5403e7509902", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0041220387014"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116572"], "spl_set_id": ["9b09b660-0758-48dc-84c9-26cdd2aacc03"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "117 mL in 1 BOTTLE (37808-316-25)", "package_ndc": "37808-316-25", "marketing_start_date": "20140305"}], "brand_name": "MAX Cold, Flu, and Sore Throat", "product_id": "37808-316_0d19111b-d15e-4e5d-a9e1-5403e7509902", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "37808-316", "generic_name": "ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MAX Cold, Flu, and Sore Throat", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140305", "listing_expiration_date": "20261231"}