theraflu expressmax severe cold and flu syrup

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name theraflu expressmax severe cold and flu syrup
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler haleon us holdings llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1, dextromethorphan hydrobromide 20 mg/1, guaifenesin 400 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-8132
Product ID 0067-8132_131940e0-559f-0aa1-e063-6394a90a779f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-07-07

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 00678132
Hyphenated Format 0067-8132

Supplemental Identifiers

RxCUI
1369842
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 theraflu expressmax severe cold and flu syrup (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
  • 20 mg/1
  • 400 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 1 SYRUP in 1 BOTTLE (0067-8132-08)
source: ndc

Packages (1)

0067-8132-08 1 SYRUP in 1 BOTTLE (0067-8132-08)

Ingredients (4)

acetaminophen (650 mg/1) dextromethorphan hydrobromide (20 mg/1) guaifenesin (400 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Theraflu ExpressMax Severe Cold and Flu Syrup ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "131940e0-559f-0aa1-e063-6394a90a779f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1369842"], "spl_set_id": ["777d2ac7-e3cc-4513-8b6f-b90b2ff2c672"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRUP in 1 BOTTLE (0067-8132-08)", "package_ndc": "0067-8132-08", "marketing_start_date": "20170707"}], "brand_name": "Theraflu ExpressMax Severe Cold and Flu Syrup", "product_id": "0067-8132_131940e0-559f-0aa1-e063-6394a90a779f", "dosage_form": "SYRUP", "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": "0067-8132", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu ExpressMax Severe Cold and Flu Syrup", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170707", "listing_expiration_date": "20261231"}