NDC | 45737-240-02 |
Set ID | 42045759-eaf2-4ffb-8a68-043f661acf8a |
Category | HUMAN OTC DRUG LABEL |
Packager | Advanced Generic Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients
- Purpose
-
Uses
- helps lossen phlegm (mucus) and thin bronchial secretions to drain broncial tubes and make coughs more productive
- temporarily relieves nasal congestion due to hay fever or other respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold
-
Warnings
Do not exceed recommended dosage
- If nervousness dizziness, or sleeplessness ocurs, discontinue use and consult a doctor
- If symptoms do not improve wihtin 7 days or are accompanied by fever, consult a doctor.
Do not use this product
- for persistant or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
- in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; if you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
Stop use and ask a doctor
- A persistent cough may be a sign of a serious condition
- if cough persists for more than onweek, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
- Keep out of reach of children
- Directions
- Inactive ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIO-G-TUSS PEDIATRIC DROPS
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-240 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg in 1 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 88 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-240-02 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2016 Labeler - Advanced Generic Corporation (831762971)