theraflu expressmax severe cold and flu caplets

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 caplets
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler haleon us holdings llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-8145
Product ID 0067-8145_131902a4-dd2f-09fa-e063-6294a90a3354
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-07-17

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 00678145
Hyphenated Format 0067-8145

Supplemental Identifiers

RxCUI
1110988
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 caplets (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0067-8145-01) / 10 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0067-8145-01 2 BLISTER PACK in 1 CARTON (0067-8145-01) / 10 TABLET, COATED in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "131902a4-dd2f-09fa-e063-6294a90a3354", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1110988"], "spl_set_id": ["8e22f6bc-33ce-4bb0-99be-7947aa21f60e"], "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": "2 BLISTER PACK in 1 CARTON (0067-8145-01)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0067-8145-01", "marketing_start_date": "20170717"}], "brand_name": "Theraflu ExpressMax Severe Cold and Flu Caplets", "product_id": "0067-8145_131902a4-dd2f-09fa-e063-6294a90a3354", "dosage_form": "TABLET, COATED", "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": "0067-8145", "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 Caplets", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170717", "listing_expiration_date": "20261231"}