FDA.reportPublic FDA data

Codeine-Guaifenesin Oral Solution

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:44:47

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 68788-7235-1
Codeine-Guaifenesin Oral Solution

10-100 mg/5 mL

Antitussive

Expectorant

Relabeled By: Preferred Pharmaceuticals Inc.

Guaifenesin & Codeine Oral Sol. 10-100mg/5mL
Guaifenesin & Codeine Oral Sol. 10-100mg/5mL

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

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-723568788-7235-1
58657-500

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CODEINE PHOSPHATEGSL05Y1MN6ACTIB
GUAIFENESIN495W7451VQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

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 · 2 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 (product): 58657-500
3972e054-af71-45f7-97c1-7ddaba6837f6bce452df-8fd2-439e-a778-cd599afc9cd62023-07-12WarningsExact identifier
spl set id: bce452df-8fd2-439e-a778-cd599afc9cd6

Reported adverse events (FAERS/openFDA)#

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