Robitussin AC

Manufacturer
Direct_Rx
Effective date
2023-02-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:38:29

Label at a glance#

ProductGUAIFEN/AC
Active ingredientGUAIFENESIN, CODEINE PHOSPHATE
Label structure15 sections

Storage and handling

Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.

Label contents#

Full prescribing information#

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.

OTC - ASK DOCTOR/PHARMACIST 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

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.

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 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.

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.

INACTIVE INGREDIENT SECTION

Caramel flavor, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.

SPL UNCLASSIFIED SECTION

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

MADE IN USA

OTC - WHEN USING SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each 5 mL = 1 tsp)

Purpose

Codeine phosphate, USP 10 mg

Cough suppressant

Guaifenesin, USP 100 mg

Expectorant

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 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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-411-0472189-411-04

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-411-04ML - Milliliter72189-4113ac30288-be6f-4f7b-9655-a2f6f5e16c9012023-02-06
70752-180-06ML - Milliliter70752-180b267459a-7991-4cc2-bcab-813d8399766b12022-09-12
70752-180-12ML - Milliliter70752-18077a1cf7d-f59b-40c1-a888-5aba599b4ff812022-09-12

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72189-41172189-411-04
70752-180

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
074cdf12-6950-c161-e063-6294a90a712bf226bd56-0621-7979-e053-2a95a90ad5f62023-10-09WarningsExact identifier
spl set id: f226bd56-0621-7979-e053-2a95a90ad5f6

Reported adverse events (FAERS/openFDA)#

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