Otc - Active Ingredient
Active Ingredients/7.5 ml: Guaifenesin 150 mg, dextromethorphan hydrobromide 15 mg
Sorbugen Syrup
FDA Label NDC 52083-660
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Sorbugen (NDC 52083-660). 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, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Expectorant, Cough Suppresant
Indications & Usage
for the temporary relief of cough due to minor throat and bronchial
irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial passages of bothersome mucus, drain bronchial tubes, and
make coughs more productive
Warnings
WarningsDo not use if you are now taking a prescription monoamine oxidase
inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional
conditions, or Parkinson's disease), or for 2 weeks after stopping the
MAOI drug. If you do not know if your prescription drug contains an
MAOI, ask a doctor or pharmacist before taking this product.
• cough that occurs with too much phlegm (mucus) • cough that lasts or is
chronic such as occurs with smoking, asthma, chronic bronchitis or
emphysema.
Ask a doctor before use if you have
When using this product do not use more than directed.
Stop use and ask a doctor if
•coughs lasts more than 7 days, comes back, or is accompanied by
fever, rash, or a persistent headache. These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep this and all medicines out of the reach of children
Otc - Pregnancy Or Breast Feeding
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
Inactive Ingredient
Inactives: Flavor, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl
Paraben, Purified Water, Sodium Citrate, Sucralose.
Package Label.Principal Display Panel
MM1
Dosage & Administration
do not take more than 6 doses in any 24-hour period
E V E RY 4 HOURS
Adults and Children 12 years of age and over 10 mL (2 tsp)
Children 6 to under 12 years of age 5 mL (1 tsp)
Children 2 to under 6 years of age 2.5 mL (½ tsp)
Children under 2 years of age Consult physician
* Please review the disclaimer below.
