FDA Label for Biospec Dmx
View Indications, Usage & Precautions
Biospec Dmx 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
Dextromethorphan HBr 10 mg.................. Cough Suppressant
Guaifenesin 187 mg .............................................. Expectorant
Otc - Purpose
Purpose
cough suppressant
expectorant
Indications & Usage
Uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold
helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Warnings
Warnings
- Do not exceed recommended dosage.
- Do not use 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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product. Ask a doctor before use if you have
- Cough that occurs with too much phlegm (mucus)
- Cough that lasts or is such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Otc - Do Not Use
Stop use and ask a doctor if
- 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 - 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions Do not take more than 8 teaspoonfuls in any 24-hour period
| adults and children 12 years of age and over | take 2 teaspoonfuls (10 mL) every 4 hours |
| children 6 years to under 12 years of age | take 1 teaspoonful every 4 hours |
| children 2 years to under 6 years of age | take 1/2 teaspoonful every 4 hours |
| children under 2 years of age | consult a doctor |
Other Safety Information
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.
Inactive Ingredient
Inactive ingredients citric acid, glycerin, methylparaben, natural and artificial flavors, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Otc - Questions
Questions or comments? 1-305-403-3788
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