maximum strength cough and congestion extended release (51316-060)

Drug Facts

Product Profile

Brand Name maximum strength cough and congestion extended release

Generic Name guaifenesin and dextromethorphan hbr

Labeler cvs pharmacy, inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 60 mg/1, guaifenesin 1200 mg/1

Manufacturer

CVS Pharmacy, Inc.

Identifiers & Regulatory

Product NDC 51316-060

Product ID 51316-060_e462b81d-0d78-4f13-b047-35aef91b50c7

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA206941

Listing Expiration 2026-12-31

Marketing Start 2024-04-01

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 51316060

Hyphenated Format 51316-060

Supplemental Identifiers

RxCUI

1099074

UNII

9D2RTI9KYH 495W7451VQ

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 maximum strength cough and congestion extended release (source: ndc)

Generic Name guaifenesin and dextromethorphan hbr (source: ndc)

Application Number ANDA206941 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

60 mg/1
1200 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (51316-060-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

51316-060-65 2 BLISTER PACK in 1 CARTON (51316-060-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (60 mg/1) guaifenesin (1200 mg/1)

Linked Drug Pages (1)

MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "e462b81d-0d78-4f13-b047-35aef91b50c7", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["13ee8bb1-9525-a5bc-e063-6294a90a9db9"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CVS Pharmacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-060-65)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-060-65", "marketing_start_date": "20240401"}], "brand_name": "MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE", "product_id": "51316-060_e462b81d-0d78-4f13-b047-35aef91b50c7", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "51316-060", "generic_name": "Guaifenesin and Dextromethorphan HBr", "labeler_name": "CVS Pharmacy, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA206941", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}