Label: G-TRON PED- dextromethorphan hbr, guiafenesin, phenylephrine hcl solution
- NDC Code(s): 52083-678-16
- Packager: Kramer Novis
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 16, 2019
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- ACTIVE INGREDIENT
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PURPOSE
Uses
- 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
- temporarily relieves nasal congestion due to a cold
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WARNINGS
Warnings
Do 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.
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DO NOT USE
Ask a doctor before use if you have
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
When using this product do not use more than directed.
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
- diabetes
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
G-TRON PED
dextromethorphan hbr, guiafenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-678 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 350 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%) (UNII: B24JYI97VR) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CITRATE (UNII: EE90ONI6FF) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-678-16 474 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/27/2014 Labeler - Kramer Novis (090158395)
