BIODESP DM- dextromethorphan, guaifenesin, phenylephrine liquid

Biodesp by

Drug Labeling and Warnings

Biodesp by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

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

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves these symptoms due to the common cold. hay fever (allergic rhinitis), or other upper respiratory allergies;
• cough due to minor throat and bronchial irritation
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bonchial tubes and make coughs more productive
• nasal congestion
• reduces swelling of nasal passages

WARNINGS

Warnings

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.

When using this product do not exceed recommended dosage

Ask a doctore before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to enlarged prostate gland
• a cough with too much phlegm (mucus)
• a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• cough lasts for more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts. These could be signs of a serious condition

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.

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 teaspoonfuls (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 teaspoonful (2.5 mL) every 6 hours
• children under 2 years of age: ask a doctor

QUESTIONS

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33147.
www.advancedgeneric.com

INACTIVE INGREDIENT

Inactive ingredients artificial flavor, citric acid, methylparaben, propylene glycol,
propylparaben, purified water, sodium citrate and sucralose.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIODESP   DM
dextromethorphan, guaifenesin, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	15 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Water (UNII: 059QF0KO0R)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Citrate (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-221-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2009

Labeler - Advanced Generic Corporation (831762971)