Label: BIO-G-TUSS PEDIATRIC DROPS- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
- NDC Code(s): 45737-240-02
- Packager: Advanced Generic Corporation
- 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 December 23, 2020
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
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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
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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
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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)
