Codeine Phosphate and Guaifenesin

Manufacturer
Noble Pharmaceuticals, LLC | BioRamo, LLC
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:22

Label at a glance#

ProductCodeine Phosphate and Guaifenesin
Active ingredientCODEINE PHOSPHATE, GUAIFENESIN
Label structure13 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants relieves 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 temporarily relieves cough associated with the common cold

Dosage and administration

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.

Storage and handling

Store at controlled room temperature 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredients (in each teaspoonful (5 mL))

OTC - ACTIVE INGREDIENT SECTION

Codeine phosphate USP 10 mg

Guaifenesin USP 100 mg

Purpose

OTC - PURPOSE SECTION

Antitussive (Cough Suppressant)

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • relieves 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
  • temporarily relieves cough associated with the common cold

OTC - ASK DOCTOR SECTION

Ask your Doctor if:

  • you have a persistent or chronic cough, this may be a sign of a serious condition
  • you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs

OTC - WHEN USING SECTION

When using this product

  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • may cause or aggravate constipation

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever, rash, or persistent headache. These may be symptoms of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

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 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry flavor, citric acid, ededate disodium, FD&C red #40, glycerin, maltodextrin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose

SPL UNCLASSIFIED SECTION

Question or Comments
Please call 1-888-514-4727

Marketed by: Noble Pharmaceuticals, LLC
Cooper City, FL 33024

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

This is an image of the label for Cheratussin AC.
This is an image of the label for Cheratussin AC.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN2
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70156-112-042022-01-28C16284748780-1d6a99b39-373d-a426-e053-dadaa90af4c2Codeine Phosphate and Guaifenesin CV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70156-112-04Codeine Phosphate and Guaifenesin118 mL in 1 BOTTLE, PLASTICLIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70156-112CODEINE PHOSPHATE AND GUAIFENESIN LIQUID [NOBLE PHARMACEUTICALS, LLC]2Legacy NDC, 1 package rows20200122_cdd50549-20b2-415a-bcd6-8348c77210c6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70156-11270156-112-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3545950b-de13-4771-a51f-21e869711a71cdd50549-20b2-415a-bcd6-8348c77210c62020-01-17WarningsExact identifier
spl id: 3545950b-de13-4771-a51f-21e869711a71
spl set id: cdd50549-20b2-415a-bcd6-8348c77210c6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.