Drug Facts
60803d28-ea6e-4ab9-9cc9-4909b4681ecd
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each tablet) Guaifenesin 100 mg
Medication Information
Warnings and Precautions
Warnings
Indications and Usage
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to:
rid the bronchial passageways of bothersome mucus
make coughs more productive
Dosage and Administration
Directions
adults and children 12 years of age and over: take 2 to 4 tablets every 4 hours, not to exceed 24 tablets (2,400 mg) in 24 hours
children 6 to under 12 years of age: take 1 to 2 tablets every 4 hours, not to exceed 12 tablets (1,200 mg) in 24 hours
children under 6 years of age: consult a doctor
Description
Active ingredients (in each tablet) Guaifenesin 100 mg
Section 44425-7
Other information
Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet
keep tightly sealed
store between 20 to 25º C (68 to 77º F)
Section 50565-1
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask a doctor if
any of the following occurs (these could be signs of a serious condition):
cough persists for more than 1 week
cough tends to recur
cough is accompanied by a fever, rash, or persistent headache
Section 50569-3
Ask a doctor before use if the user has
a persistent or chronic cough such as occurs with:
smoking
asthma
chronic bronchitis
emphysema
a cough that is accompanied by excessive phlegm (mucus)
a high fever
Section 51727-6
Inactive ingredients aspartame, colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate.
Section 51945-4
EXCAUGH
Guaifenesin - Expectorant
NDC 51467-009-02
36 Tablets
Section 53413-1
Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to this phone number
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Expectorant
Section 55106-9
Active ingredients (in each tablet)
Guaifenesin 100 mg
Structured Label Content
Indications and Usage (34067-9)
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to:
rid the bronchial passageways of bothersome mucus
make coughs more productive
Dosage and Administration (34068-7)
Directions
adults and children 12 years of age and over: take 2 to 4 tablets every 4 hours, not to exceed 24 tablets (2,400 mg) in 24 hours
children 6 to under 12 years of age: take 1 to 2 tablets every 4 hours, not to exceed 12 tablets (1,200 mg) in 24 hours
children under 6 years of age: consult a doctor
Warnings and Precautions (34071-1)
Warnings
Section 44425-7 (44425-7)
Other information
Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet
keep tightly sealed
store between 20 to 25º C (68 to 77º F)
Section 50565-1 (50565-1)
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
any of the following occurs (these could be signs of a serious condition):
cough persists for more than 1 week
cough tends to recur
cough is accompanied by a fever, rash, or persistent headache
Section 50569-3 (50569-3)
Ask a doctor before use if the user has
a persistent or chronic cough such as occurs with:
smoking
asthma
chronic bronchitis
emphysema
a cough that is accompanied by excessive phlegm (mucus)
a high fever
Section 51727-6 (51727-6)
Inactive ingredients aspartame, colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate.
Section 51945-4 (51945-4)
EXCAUGH
Guaifenesin - Expectorant
NDC 51467-009-02
36 Tablets
Section 53413-1 (53413-1)
Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to this phone number
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Expectorant
Section 55106-9 (55106-9)
Active ingredients (in each tablet)
Guaifenesin 100 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:13.108886 · Updated: 2026-03-14T23:10:28.026216