Gadavyt Cough
FDA Label NDC 53113-550

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories Inc for the product Gadavyt Cough (NDC 53113-550). 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, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, 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 5 mL tsp.)              Purpose

Guaifenesin 100mg                                          Expectorant

Otc - Purpose

USES
Helps loosen phlegm (mucus) and thin bronchial
secretions to make coughs more productive

Warnings

Warnings
Ask a doctor before use if

  • you have cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • cough occurs with too much phlegm (mucus)

Otc - Do Not Use

Stop use and ask a doctor if

  • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of
overdose, get medical help or contact a Poison Control Center
right away.

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration

Directions

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

adults and children 12 years and over
2-4 TSP every 4 hours or as directed by doctor
children under 12 years
do not use

Indications & Usage

Other information
store at room temperature  15 - 30 degrees C (59 - 86 degrees F)
TAMPER-EVIDENT: Do not use if seal under cap is torn,
broken or missing.

Inactive Ingredient

Inactive Ingredients
Citric acid, menthol, methylparaben, propylparaben, glycerin,
sucralose, sodium citrate, FD and C Red No. 40, caramel color,
cherry flavor, natrosol, purified water.

Otc - Questions

GADAL Laboratories, Inc.

Miami, Fl 33186

www.gadallaboratories.com

Package Label.Principal Display Panel

Coughlabel (Coughlabel)

Coughlabel (Coughlabel)

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