CODEINE-GUAIFENESIN

Manufacturer
Direct Rx
Effective date
2022-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:06:57

Label at a glance#

ProductCODEINE-GUAIFENESIN
Active ingredientGUAIFENESIN, CODEINE PHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mg Expectorant

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE 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 make coughs more productive.

WARNINGS SECTION

Ask your doctor before use if

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

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

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, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING 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 SAFETY INFORMATION

Store at controlled room temperature 15°-30°C (59°-86°F).

You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.

INACTIVE INGREDIENT SECTION

Cherry Flavor, Citric Acid Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-337-04ML - Milliliter72189-337f536c6f6-5f2d-4d67-b778-31af8551250b12022-04-06

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
72189-33772189-337-04
69367-272

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
074b7240-abe5-8c7b-e063-6294a90a0b30d9a75569-10bc-451d-e053-2995a90a5b372023-10-09WarningsExact identifier
spl set id: d9a75569-10bc-451d-e053-2995a90a5b37

Reported adverse events (FAERS/openFDA)#

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