Otc - Active Ingredient
Actives in each 1 ml: Guaifenesin 50 mg, Dextromethorphan Hydrobromide 5 mg, Phenylephrine Hydrochloride 2.5 mg
G-supress Dx Syrup
FDA Label NDC 52083-655
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 G-supress Dx (NDC 52083-655). 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, dosage & administration, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Expectorant, cough suppressant, nasal decongestant
Indications & Usage
helps loosen phlegm (mucus) and thin bronchial
secretions to drain bronchial tubes and make coughs
more productive
• temporarily relieves:
• nasal congestion due to hay fever or other upper
respiratory allergies (allergic rhinitis)
• cough due to minor throat and bronchial irritation
as may occur with the common cold
Dosage & Administration
Directions
• do not use more than 6
doses in any 24-hour
period.
• repeat every 4 hours.
• measure with the dosage
device provided. Do not
use with any other device.
• children 2 to under 6
years of age, 1 mL.
• children under 2 years of
age, consult a doctor.
Warnings
Warnings
Do not use in a child who 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 child’s
prescription drug contains a MAOI, ask a doctor or
pharmacist before giving this product.
Stop use and ask a doctor if• your child gets nervous,
dizzy, or sleepless• symptoms do not get better
within 7 days or are accompanied by fever
• cough lasts more than 7days, comes back, or is accompanied by fever,
r a s h , o r p e r s i s t e n t headache. These could be
signs of a serious condition.
When using this product do not exceed recommended dosage.
Ask a doctor before use if the child has
• heart disease • thyroid disease • high blood pressure• diabetes
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with asthma.
Otc - Pregnancy Or Breast Feeding
As with any drug, if you are pregnant or nursiong a baby, consult a health professional before using this product
Otc - Keep Out Of Reach Of Children
Keep out of reach of c h i l d r e n . I n c a s e o f accidental overdose, get medical help or contact a
Poison Control Center right away.
Inactive Ingredient
Inactive Ingredients: Citric Acid, Flavor, Glycerin, Red 40, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sodium Saccharin,
* Please review the disclaimer below.
