Codeine-Guaifenesin

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2025-05-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:00:58

Key Label Information#

Uses

Uses

temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Warnings

Directions And Dosage

Directions

do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

Other Label Information

Other information

Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.

Inactive Ingredients

Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 69367-272-16 Codeine- Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive/Expectorant Sugar Free, Alcohol Free, Dye Free Each 5 mL (1 teaspoonful) contains: Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg (WARNING: May be habit-forming) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. 16 fl. oz. (473 mL) Westminster Pharmaceuticals

Label Images#

codeine-01
codeine-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN6
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD6
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CODEINE ANHYDROUS Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-272-04Codeine-Guaifenesin118 mL in 1 BOTTLESOLUTION1186
69367-272-16Codeine-Guaifenesin473 mL in 1 BOTTLESOLUTION4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-272CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [WESTMINSTER PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20250515_3da3efd7-e278-4d79-9130-eef3992097e4.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69367-27269367-272-04, 69367-272-16

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69367-272-16 Codeine- Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive/Expectorant Sugar Free, Alcohol Free, Dye Free Each 5 mL (1 teaspoonful) contains: Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg (WARNING: May be habit-forming) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. 16 fl. oz. (473 mL) Westminster Pharmaceuticals

Source Document#

Source XML