Respiratory Relief

Respiratory Relief
SPL v1
SPL
SPL Set ID f683041a-4ff9-42a5-9047-a9a3140a8758
Route
ORAL
Published
Effective Date 2025-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Carnauba Wax Microcrystalline Cellulose Glycerin Hypromellose, Unspecified Magnesium Stearate Maltodextrin Povidone Silicon Dioxide Croscarmellose Sodium Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 400 Shape: oval Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-29

Description

Guaifenesin 400 mg

Purpose

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.


Medication Information

Purpose

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Description

Guaifenesin 400 mg

Section 51945-4

Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, tends to recur, or is accompanied by a fever, rash or persisient headache.

A persistent cough may be a sign of a serious condition.

Warnings

Do not use for children under 12 years of age.

Overdosage:

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

Ask A Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough accompanied by excessive phlegm (mucus).

Active Ingredient

Guaifenesin 400 mg

Indications & Usage

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Inactive Ingredients

Carnauba Wax

Cellulose

Glycerin

Hypromellose

Magnesium Stearate

Maltodextrin

Povidone

Silica

Sodium Croscarmellose

Stearic Acid

Dosage & Administration

Adults & children 12 years of age and older:  take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not to exceed 6 tablets in 24 hours.

Children under 12 years of age: do not use.

Pregnant Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Section 51945-4 (51945-4)

Purpose

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, tends to recur, or is accompanied by a fever, rash or persisient headache.

A persistent cough may be a sign of a serious condition.

Warnings

Do not use for children under 12 years of age.

Overdosage:

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

Ask A Doctor (Ask a doctor)

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough accompanied by excessive phlegm (mucus).

Active Ingredient

Guaifenesin 400 mg

Indications & Usage

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Inactive Ingredients

Carnauba Wax

Cellulose

Glycerin

Hypromellose

Magnesium Stearate

Maltodextrin

Povidone

Silica

Sodium Croscarmellose

Stearic Acid

Dosage & Administration

Adults & children 12 years of age and older:  take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not to exceed 6 tablets in 24 hours.

Children under 12 years of age: do not use.

Pregnant Or Breast Feeding (Pregnant or Breast Feeding)

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children (Keep out of Reach of Children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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