FDA Label for Biogtuss TR
View Indications, Usage & Precautions
Biogtuss TR Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Generic Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each tablet) Purpose
Dextromethorphan HBR .... 28 mg ............ Cough Suppressant
Guaifenesin ..................... 388 mg ........... Expectorant
Phenylephrine HCl ............ 10 mg .......... Nasal Decongestant
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Indications & Usage
Uses
Temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies
- helps loosen phlegm (mucus)
- loosens nasal congestion
- thin bronchial secretions
- drain bronchial tubes
- cough and coughing and calms the cough control center
- make coughs more productive
- clears stuffy nose
- clear nasal passageways
- shrinks swollen membranes
Warnings
Warnings
Do not exceed recommended dosage
Do not use this product if you are taking a 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.
Ask a doctor before use if you have:
- heart disease
- excessive phlegm (mucus)
- high blood pressure
- diabetes
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
When using this product do not use more than directed
Otc - Stop Use
Stop use and ask a doctor if:
- Nervousness, dizziness, or sleeplessness occurs
- symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
- cough and congestion do not improve within 7 days or are accompanied by fever or symptoms tend to recur.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding. Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions: Do not exceed recommended doses in a 24-hour period
Adults and children 12 years of age and over 1 tablet every 4 hours. Do not exceed 4 tablets in 24 hours
Children 6 to 12 years of age 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours
Children under 6 years of age Ask a doctor
Inactive Ingredient
Inactive ingredients: Colloidal silicon dioxide, crocarmellose sodium, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, talc
Otc - Questions
Questions or comments? 305-403-3788
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