Cough Out

Cough Out
SPL v9
SPL
SPL Set ID fe4c3921-8d30-4cd6-ba90-9211b362a38a
Route
ORAL
Published
Effective Date 2020-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Aloe Vera Leaf Honey Menthol Potassium Sorbate Propylene Glycol Propylparaben Methylparaben Water Aspartame

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1997-07-01 Until 2026-10-31

Description

Active Ingredient: (In each teaspoonful 5 mls)         Purpose Guiafenesin 100 mg (USP)............................................Expectorant


Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage

Ask a doctor before use if you have

  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persstent headached. A persistent cough may be a sign of a serious condition.

Indications and Usage

Uses

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

Dosage and Administration

Directions:

Shake well immediately before use.

Do not exceed 6 doses in any 24 hour period. 

Adults and Children 12 years and over - 10 ml (2 tsps) every 4 hours

Children 6 to under 12 years of age - 5 ml (1 tsp) every 4 hours

Children under 6 years of age - Do not use

Description

Active Ingredient: (In each teaspoonful 5 mls)         Purpose Guiafenesin 100 mg (USP)............................................Expectorant

Section 50565-1

Keep Out of Reach of Children.

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

Section 51727-6

Inactive Ingredients:Aloe Vera, Aspartame, Honey, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water

Section 51945-4

Section 53413-1

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com



Section 53414-9

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

Section 55105-1

Purpose Expectorant

Section 55106-9

Active Ingredient: (In each teaspoonful 5 mls)         Purpose

Guiafenesin 100 mg (USP)............................................Expectorant

Section 60561-8

Each 5 mls contains: sodium 5 mg, and potassium 5 mg

Phenylketonurics: Contains Phenylalanine 2.5 mg per 5 ml (teaspoonful). 


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.

Dosage and Administration (34068-7)

Directions:

Shake well immediately before use.

Do not exceed 6 doses in any 24 hour period. 

Adults and Children 12 years and over - 10 ml (2 tsps) every 4 hours

Children 6 to under 12 years of age - 5 ml (1 tsp) every 4 hours

Children under 6 years of age - Do not use

Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage

Ask a doctor before use if you have

  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persstent headached. A persistent cough may be a sign of a serious condition.

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

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

Section 51727-6 (51727-6)

Inactive Ingredients:Aloe Vera, Aspartame, Honey, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com



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 Ingredient: (In each teaspoonful 5 mls)         Purpose

Guiafenesin 100 mg (USP)............................................Expectorant

Section 60561-8 (60561-8)

Each 5 mls contains: sodium 5 mg, and potassium 5 mg

Phenylketonurics: Contains Phenylalanine 2.5 mg per 5 ml (teaspoonful). 


Advanced Ingredient Data


Raw Label Data

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