FDA.reportPublic FDA data

Guaifenesin and Codeine Phosphate

Manufacturer
A-S Medication Solutions
Effective date
2024-02-13
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:08:38

Label at a glance#

ProductGuaifenesin and Codeine Phosphate
Active ingredientGUAIFENESIN, CODEINE PHOSPHATE
Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Dosage and administration

take every 4 hours do not exceed 6 doses in 24 hours a special measuring device should be used to give an accurate dose of this product to children under 6 years of age giving a higher dose than recommended by a doctor can result in serious side effects for a child adults and children 12 years and over 10 mL (2 teaspoonfuls) children 6 to under 12 years of age 5 mL (1 teaspoonful) children under 6 years of age Con...

Storage and handling

Sodium Content: 5 mg/5 mL Tamper evident: Do not use if seal under cap is broken or missing Keep container closed and store away from heat Store at 20°- 25°C (68°-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients in each 5 mL (teaspoonful)Purposes
Codeine Phosphate, USP 10 mgCough Suppressant
Guaifenesin, USP 100 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
  • may cause or aggravate constipation

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Use of codeine-containing preparation is not recommended for children under 2 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 hours
  • do not exceed 6 doses in 24 hours
  • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • giving a higher dose than recommended by a doctor can result in serious side effects for a child
adults and children 12 years and over10 mL (2 teaspoonfuls)
children 6 to under 12 years of age5 mL (1 teaspoonful)
children under 6 years of ageConsult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Sodium Content: 5 mg/5 mL
  • Tamper evident: Do not use if seal under cap is broken or missing
  • Keep container closed and store away from heat
  • Store at 20°- 25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210 or visit paipharma.com

Serious side effects associated with use of this product may be reported to this number.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1428

NDC: 50090-1428-0 118 mL in a BOTTLE

Guaifenesin and Codeine Phosphate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN9
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD9
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY9

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
50090-1428-02023-02-07C16284748780-1f386c64a-10db-0266-e053-dadaa90a7c1aGuaifenesin and Codeine Phosphate
50090-1428-02023-01-30C16284748780-1f386c64a-10db-0266-e053-dadaa90a7c1aGuaifenesin and Codeine Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1428-0Guaifenesin and Codeine Phosphate118 mL in 1 BOTTLESOLUTION1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1428GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20240215_36140639-e7a8-43bc-83e2-469430af9d1a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1428-0ML - Milliliter50090-1428930d9412-ce4f-4e9b-83e9-694d9666bccf12018-11-06
0121-0775-04ML - Milliliter0121-0775ac9f8c15-4f02-4667-b975-5c20f7d93dab12012-07-24
0121-0775-08ML - Milliliter0121-0775ef3933a2-ccb0-4b44-977e-b6b8f9f14e1212018-02-20
0121-0775-16ML - Milliliter0121-0775270b5b4b-ceb0-4155-ad98-6b3454cf2a2912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN61
GuaifenesinACTIVE INGREDIENT495W7451VQ1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7J1
GuaifenesinACTIVE MOIETY495W7451VQ1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-142850090-1428-0
0121-0775

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
CODEINE PHOSPHATEGSL05Y1MN6ACTIB
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
ndc (product): 0121-0775
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEA-S Medication Solutions36140639-e7a8-43bc-83e2-469430af9d1a2024-02-13WarningsExact identifier
ndc (package): 50090-1428-0
ndc (product): 50090-1428
ndc11 (package): 50090142800
spl id: b5a8f590-413c-440b-9908-ad84f627824a
spl set id: 36140639-e7a8-43bc-83e2-469430af9d1a

Reported adverse events (FAERS/openFDA)#

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