SPL v1
SPL
SPL Set ID 6f6f3aae-a676-4b91-bad3-2a1c798ffe0a
Route
ORAL
Published
Effective Date 2013-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Menthol Sucrose Sorbitol Sodium Benzoate Bronopol Edetic Acid Aspartame Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-01

Description

Expectorant

Purpose

Expectorant


Medication Information

Purpose


Expectorant
Description

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Section 51727-6

BRONOPOL

Section 51945-4
Section 55106-9
GUAIFENESIN
Warning

Ask a doctor before use if you have



•cough that occurs with too much phlegm (mucus)

•cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema



Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.















Direction

•do not take more than 6 doses in any 24-hour period

•this adult product is not intended for use in children under 12 years of age

age dose

adults and children 12 years and over: 2-4 teaspoons every 4 hours



children under 12 years: do not use

Inactive Ingredient

ASPARTAME

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses (uses)

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Section 51727-6 (51727-6)

BRONOPOL

Section 51945-4 (51945-4)
Section 55106-9 (55106-9)
GUAIFENESIN
Purpose (purpose)


Expectorant
Warning (warning)

Ask a doctor before use if you have



•cough that occurs with too much phlegm (mucus)

•cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema



Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.















Direction (direction)

•do not take more than 6 doses in any 24-hour period

•this adult product is not intended for use in children under 12 years of age

age dose

adults and children 12 years and over: 2-4 teaspoons every 4 hours



children under 12 years: do not use

Inactive Ingredient (inactive ingredient)

ASPARTAME

Keep Out of Reach of Children (keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)