Biodesp DM

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 15mg in 5mL, Guaifenesin 100mg in 5mL, Phenylephrine Hydrochloride 5mg in 5mL
Labeler: Advanced Generic Corporation
NDC Code: 45737-221

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients: (in each 5 mL tsp.)              Purpose

Guaifenesin 100 mg .............................................. Expectorant

Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

Phenylephrine HCl 5 mg.................................. Decongestant

Uses
  • Indicated for the symptomatic relief of sinusitis, bronchitis, pharyngitis, relief of cough due to colds due minor upper respiratory infections

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.

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)
(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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor.

Keep out of reach of children.

If pregnant or breast-feeding, ask a health professional before use.

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

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.

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

Inactive ingredients Glycerin, flavor, methylparaben, propylene glycol,
propylparaben, purified water, sodium citrate, sodium saccharin and sorbitol.

BIODESP   DM
dextromethorphan, guaifenesin, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-221
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Water 
Methylparaben 
Propylparaben 
Propylene Glycol 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45737-221-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2009
Labeler - Advanced Generic Corporation (831762971)

Revised: 08/2011
 
Advanced Generic Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)