FDA Label for Biogtuss
View Indications, Usage & Precautions
Biogtuss 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 5 mL tsp.) Purpose
Guaifenesin 300 mg .............................................. Expectorant
Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant
Phenylephrine HCl 10 mg.................................. Decongestant
Otc - Purpose
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
- temporarily relieves nasal congestion and cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants.
Warnings
Warnings
- Do not exceed recommended dosage
- A
persistent cough may be a sign of a serious condition. If cough
persists for more than a week, tends to reoccur or is accompanied by a
fever, rash or persistent headache, consult a doctor
- May cause or aggravate constipation
- If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
- If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
Otc - Do Not Use
Do not Use
- For
persistent cough such as occurs with smoking, asthma, chronic
bronchitis, emphysema or where cough is accompanied by excessive phelgm
(mucus), unless directed by a doctor
- If you have a
chronic pulmonary disease or shortness of breath, children who are
taking other drugs, unless directed by a doctor.
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor.
(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 you are taking a prescription drug that contains an MAOI;
ask your doctor or pharmacist before taking this product.
If you have
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions Do not exceed 6 doses in 24 hours.
adults and children 12 years of age and over take 1 teaspoonful (5 mL) every 4 hours
children 6 to under 12 years of age take 1/2 teaspoonful (2.5 mL) every 4 hours
children under 6 years of age ask a doctor
Indications & Usage
Other information store at room temperature 15°- 30°C (59° - 86°F).
Tamper Evident Feature: Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.
Warning:Phenylketonuric. Contains 17 mg of Phenylalanine per 5 mL (one teaspoonful dose).
Inactive Ingredient
Inactive Ingredients aspartame, citric acid, D and C Red No 33, FD and C Blue No 1, glycerine, hydroxymethyl cellulose, methylparaben, natural and artificial flavors, propylene glycol, propylparaben, purified water, sodium citrate
Otc - Questions
Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, Fl 33166
www.advancedgeneric.com
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