FDA.reportPublic FDA data

Codeine-Guaifenesin Oral Solution

Manufacturer
Method Pharmaceuticals, LLC
Effective date
2026-04-01
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:57:15

Label at a glance#

ProductCodeine-Guaifenesin
Active ingredientCODEINE PHOSPHATE, GUAIFENESIN
Label structure10 sections

Indications and 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 makes cough more productive.

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 15°-30°C (59°-86°F).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each teaspoonful (5 mL))
Codeine Phosphate USP 10 mg

Purpose

OTC - PURPOSE SECTION

Antitussive

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each teaspoonful (5 mL))
Guaifenesin USP 100 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

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 makes cough more productive.

Warnings

WARNINGS SECTION

Ask your doctor before use if

OTC - ASK DOCTOR SECTION

  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent 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

When using this product

OTC - WHEN USING SECTION

  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 15°-30°C (59°-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58657-500-16



Codeine-Guaifenesin Oral Solution



10-100 mg/5 mL



Antitussive



Expectorant



16 fl. oz. (473 mL)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN16
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD16
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY16

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
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
58657-500-042020-02-11C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-042020-02-11C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-042020-02-11C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-162020-02-11C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-162020-02-11C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-162020-02-11C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-042020-01-31C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-042020-01-31C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-042020-01-31C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-162020-01-31C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-162020-01-31C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution
58657-500-162020-01-31C16284748780-19d75b9d0-62ad-f424-e053-dadaa90a57ceCodeine-Guaifenesin Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-500-04Codeine-Guaifenesin120 mL in 1 BOTTLESOLUTION12016
58657-500-16Codeine-Guaifenesin473 mL in 1 BOTTLESOLUTION47316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-500-04ML - Milliliter58657-500165585be-2a2d-4c03-b517-ef66f56bcc4a12014-07-02
58657-500-16ML - Milliliter58657-500b91df96f-0171-473c-9a97-463f578234c312014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN65
GUAIFENESINACTIVE INGREDIENT495W7451VQ5
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7J5
GUAIFENESINACTIVE MOIETY495W7451VQ5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP5
GLYCERININACTIVE INGREDIENTPDC6A3C0OX5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V35
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR5
SORBITOLINACTIVE INGREDIENT506T60A25R5
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58657-50058657-500-04, 58657-500-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
CODEINE PHOSPHATEGSL05Y1MN6ACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152025-10-21monthly-update2026-06-03 17:39:02
142024-11-20full-release2026-06-01 00:38:59

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINMethod Pharmaceuticals, LLCfe126254-6ee6-48c3-965c-96e4276a53142026-04-01WarningsExact identifier
ndc (package): 58657-500-16
ndc (package): 58657-500-04
ndc (product): 58657-500
ndc11 (package): 58657050004
ndc11 (package): 58657050016
spl id: 4e6980b2-573c-2636-e063-6294a90ac0f4
spl set id: fe126254-6ee6-48c3-965c-96e4276a5314

Reported adverse events (FAERS/openFDA)#

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