FDA.reportPublic FDA data

Guaifenesin and Codeine Phosphate

Manufacturer
PAI Holdings, LLC | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2024-09-06
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:19:06

Label at a glance#

ProductGuaifenesin and Codeine Phosphate
Active ingredientGUAIFENESIN, CODEINE PHOSPHATE
Label structure11 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 aretaking 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.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0775-16

Guaifenesin and Codeine
Phosphate Oral Solution USP
CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Each teaspoonful (5 mL) contains:
Guaifenesin, USP 100 mg
Codeine Phosphate, USP 10 mg

Dispense in a tight, light-resistant
container with a child-resistant closure.

DO NOT ACCEPT IF SEAL
AROUND CAP IS BROKEN OR MISSING

16 fl oz (473 mL)

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Principal Display Panel - 473 mL Bottle Label
Principal Display Panel - 473 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-1775-05

G UAIFENESINAND C ODEINEP HOSPHATE 

O RALS OLUTIONUSP CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label
PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1550-10

G UAIFENESINAND C ODEINEP HOSPHATE

O RALS OLUTIONUSP CV

200 mg/20 mg per 10 mL

Expectorant / Cough Suppressant
Alcohol Free / Sugar Free

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel - 10 mL Unit Dose Cup Label - 1775
Principal Display Panel - 10 mL Unit Dose Cup Label - 1775

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN11
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD11
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY11

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
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
0121-0775-042022-03-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-0775-082022-03-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-0775-162022-03-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-1550-002022-03-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-1775-002022-03-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-1775-102022-03-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-0775-042022-01-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-0775-082022-01-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-0775-162022-01-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-1550-002022-01-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-1775-002022-01-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate
0121-1775-102022-01-28C16284748780-1d6a99b39-4ea2-a426-e053-dadaa90af4c2Guaifenesin and Codeine Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0775-04Guaifenesin and Codeine Phosphate118 mL in 1 BOTTLESOLUTION11811
0121-0775-08Guaifenesin and Codeine Phosphate237 mL in 1 BOTTLESOLUTION23711
0121-0775-16Guaifenesin and Codeine Phosphate473 mL in 1 BOTTLESOLUTION47311
0121-1550-00Guaifenesin and Codeine Phosphate10 in 1 TRAYSOLUTION1011
0121-1550-00Guaifenesin and Codeine Phosphate10 in 1 CASESOLUTION1011
0121-1550-10Guaifenesin and Codeine Phosphate10 mL in 1 CUP, UNIT-DOSESOLUTION1011
0121-1550-40Guaifenesin and Codeine Phosphate10 in 1 TRAYSOLUTION1011
0121-1550-40Guaifenesin and Codeine Phosphate4 in 1 CASESOLUTION411
0121-1775-00Guaifenesin and Codeine Phosphate10 in 1 TRAYSOLUTION1011
0121-1775-00Guaifenesin and Codeine Phosphate10 in 1 CASESOLUTION1011
0121-1775-05Guaifenesin and Codeine Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION511
0121-1775-10Guaifenesin and Codeine Phosphate10 in 1 CASESOLUTION1011
0121-1775-10Guaifenesin and Codeine Phosphate10 in 1 TRAYSOLUTION1011
0121-1775-40Guaifenesin and Codeine Phosphate4 in 1 CASESOLUTION411
0121-1775-40Guaifenesin and Codeine Phosphate10 in 1 TRAYSOLUTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0775GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC]11Current NDC, Legacy NDC, 3 package rows20240907_88d0994c-4270-4408-8837-bd97510b2118.zip
0121-1550GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC]11Current NDC, Legacy NDC, 5 package rows20240907_88d0994c-4270-4408-8837-bd97510b2118.zip
0121-1775GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC]11Current NDC, Legacy NDC, 7 package rows20240907_88d0994c-4270-4408-8837-bd97510b2118.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
0121-1775-00ML - Milliliter0121-1775fdafec21-258c-4805-9ff7-66930e2484d412017-08-11
0121-1775-05ML - Milliliter0121-17754eac12b0-97b2-4ef1-bef3-888760717dfa12012-07-24
0121-1775-10ML - Milliliter0121-1775fe8b87eb-c801-465e-91f8-5a36471e2a4312012-07-24
0121-1775-40ML - Milliliter0121-177583b2dba4-69f5-4ad4-ad62-88c4211f618412024-02-14
0121-1550-00ML - Milliliter0121-1550b69d5b9d-f7c2-4d33-9f44-67c832179cf212017-08-11
0121-1550-10ML - Milliliter0121-1550dee23321-cef1-46cb-8d6c-347c5e81ccb612017-08-11
0121-1550-40ML - Milliliter0121-1550cdc60019-dabf-48fa-90f2-cd3a54928f5d12024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN61
GuaifenesinACTIVE INGREDIENT495W7451VQ1
CodeineACTIVE MOIETYQ830PW75201
GuaifenesinACTIVE MOIETY495W7451VQ1

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
0121-07750121-0775-04, 0121-0775-08, 0121-0775-16
0121-17750121-1775-05, 0121-1775-00, 0121-1775-10, 0121-1775-40
0121-15500121-1550-10, 0121-1550-00, 0121-1550-40

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
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
GUAIFENESIN495W7451VQACTIB
CODEINE PHOSPHATEGSL05Y1MN6ACTIB
SODIUM CITRATE1Q73Q2JULRIACT
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
GUAIFENESIN495W7451VQACTIB
CODEINE PHOSPHATEGSL05Y1MN6ACTIB
SODIUM CITRATE1Q73Q2JULRIACT
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

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
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
ndc (package): 0121-1550-40
ndc (package): 0121-1775-00
ndc (package): 0121-1550-10
ndc (package): 0121-0775-16
ndc (package): 0121-1550-00
ndc (package): 0121-1775-10
ndc (package): 0121-0775-04
ndc (package): 0121-0775-08
ndc (package): 0121-1775-05
ndc (package): 0121-1775-40
ndc (product): 0121-0775
ndc (product): 0121-1550
ndc (product): 0121-1775
ndc11 (package): 00121077508
ndc11 (package): 00121177505
ndc11 (package): 00121155040
ndc11 (package): 00121177540
ndc11 (package): 00121177510
ndc11 (package): 00121177500
ndc11 (package): 00121077516
ndc11 (package): 00121155000
ndc11 (package): 00121155010
ndc11 (package): 00121077504
spl id: 2175415b-f07e-50a6-e063-6394a90acabe
spl set id: 88d0994c-4270-4408-8837-bd97510b2118

Reported adverse events (FAERS/openFDA)#

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