FDA Label for Bionel Pediatric
View Indications, Usage & Precautions
Bionel Pediatric 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 50 mg .............................................. Expectorant
Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant
Pseudoephedrine HCl 15 mg.................................. Nasal Decongestant
Otc - Purpose
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves these symptoms occurring with a cold: nasal congestion, cough due to minor throat and bronchial irritation.
Warnings
Warnings
Do not use in a child who is 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 you are
taking a prescription drug that contains a MAOI; ask a doctor or
pharmacist before taking this product.
Otc - Do Not Use
Ask a doctor before use if your child have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to the enlargement of the prostate gland
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition. Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or accompanied by fever
- cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
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 more than 4 doses in any 24-hour period or as directed by a doctor.Children 6 to under 12 years of age; 45 lbs to under 95 lbs; Take 2 teaspoonfuls (10mL) every 4 to 6 hoursChildren 2 to under 6 years of age; 25 lbs to under 45 lbs; Take 1 teaspoonful (5mL) every 4 to 6 hoursChildren under 2 years of age; Under 25 lbs; Ask a doctor
Indications & Usage
Other information
- store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
Inactive Ingredient
Inactive ingredients aspartame, citric acid, corn syrup, D and C Red No 33, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water.
Otc - Questions
Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, Fl 33166
www.advancedgeneric.com
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