FDA Label for Bisolvine Child
View Indications, Usage & Precautions
Bisolvine Child Product Label
The following document was submitted to the FDA by the labeler of this product Pharmalab Enterprises Inc.. 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) Purpose
Guaifenesin 100 mg ................................................ Expectorant
Dextromethorphan.............................................. Cough Suppressant
Otc - Purpose
Uses
* temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Warnings
Warnings: Do not exceed recommended dosage.
A persistent or chronic cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Otc - Do Not Use
Do not use:
* this product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
* If you are now 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Other Information
Other Information
- store this product between (15 to 30 C) (59 to 86 C) Distributed by Menper Distributors, Inc.
6500 N.W. 35th Ave., Miami, Fl, 33147
www.menperdistributors.com
Directions
Directions
- Do not exceed 6 doses in 24 hours
Age Dose
Children 6 to under 1 tablespoonful (15 mL)
12 years of age every 4 hours
Children 2 to under 1/2 tablespoonful (7.5 mL)
6 years of age every 4 hours
Children under 2 years of age Consult your doctor
Package Label.Principal Display Panel
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