Otc - Active Ingredient
Active Ingredients in each 1 ml: Guaifenesin 50 mg, dextromethorphan hydrobromide 5 mg
Supress Dm Syrup
FDA Label NDC 52083-058
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 Supress Dm (NDC 52083-058). 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
Cough Suppressant, Expectorant
Indications & Usage
suppresses cough due to minor throat and bronchial irritation associated with
a cold or inhaled irritants
• 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 if a child is 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.
Ask a doctor before use for:A cough that occurs with too much phlegm (mucus)-Cough that lasts or is chronic such as occurs with asthma
Stop use and ask a doctor if: new symptoms occur•symptoms do not get better within 7 days or are accompanied by fever
•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: Citric Acid, Cherry FlavorFlavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl
Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin.
Package Label.Principal Display Panel
MM1
Dosage & Administration
Children 2-6 years, 1 mL every 4 hours as needed, Do not exceed 6 doses in any 24-hour, or as directed by a doctor
Children under 2 years, consult a doctor
neasure with the dosage device provided. Do not use with any other device.
* Please review the disclaimer below.
