Cough Out Liquid
FDA Label NDC 58593-255

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories Inc. for the product Cough Out (NDC 58593-255). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: (In each teaspoonful 5 mls)         Purpose

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

Otc - Purpose

Purpose Expectorant

Indications & Usage

Uses

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

Warnings

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.

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children.

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

Otc - Pregnancy Or Breast Feeding

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

Dosage & 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

Inactive Ingredient

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

Other Safety Information

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

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

Otc - Questions

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com


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Coughoutlabel (Coughout)

Coughoutlabel (Coughout)

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