Guaap
FDA Label NDC 46084-051

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A P J Laboratories Limited for the product Guaap (NDC 46084-051). 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 purpose, keep out of reach of children, uses, warning, direction, inactive ingredient, otc - active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Expectorant

Keep Out Of Reach Of Children

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

Uses

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

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

BRONOPOL

EDETIC ACID

MENTHOL


SUCROSE

SODIUM BENZOATE

SORBITOL

XANTHAN GUM

Otc - Active Ingredient

GUAIFENESIN

* Please review the disclaimer below.