The following Structured Product Label (SPL) was submitted to the FDA by Wittman Pharma, Inc. for the product Curatussin (NDC 83335-101). 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 dosage & admin, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions:
■ do not take more than 6 doses in any 24-hour period.
| AGE | DOSE |
| Adults & Children 12 years and over | 2-4 teaspoonfuls every 4 hours |
| Children 6 years to under 12 years | 1-2 teaspoonfuls every 4 hours |
| Children 2 to under 6 years | 1/2 - 1 teaspoonfuls every 4 hours |
| Children Under 2 years | Ask a Doctor |
Warnings:
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 more than 7 days, comes
back, or is accompanied by fever, rash or persistent headache.
These could be signs of a serious condition.
If pregnant of breast-feeding, ask a health professional before
use. Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose
Uses:
■ helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Purpose: Expectorant
Active Ingredient (in each 5 mL tsp)
Guaifenesin 100 mg
* Please review the disclaimer below.
