FDA Label for Biodesp DM
View Indications, Usage & Precautions
Biodesp DM 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 100 mg .............................................. Expectorant
Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant
Phenylephrine HCl 5 mg.................................. Decongestant
Otc - Purpose
Uses
- Indicated for the symptomatic relief of sinusitis, bronchitis, pharyngitis, relief of cough due to colds due minor upper respiratory infections
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. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.
- Do not give this product to a child who has
- heart disease
- high blood pressure
- thyroid disease
- diabetes unless directed by a doctor. If you are now taking a prescription monoamine oxidase inhibitor (MAOI)
- 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 4 doses in 24 hours.
adults and children 12 years of age and over take 2 teaspoonful (10 mL) every 6 hours
children 6 to under 12 years of age take 1 teaspoonful (5 mL) every 6 hours
children 2 to under 6 years of age take 1/2 teaspooful (2.5 mL) every 6 hours
children under 2 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.
Otc - Questions
Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com
Inactive Ingredient
Inactive ingredients Glycerin, flavor, methylparaben, propylene glycol,
propylparaben, purified water, sodium citrate, sodium saccharin and sorbitol.
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