BIODESP DM NF- dextromethorphan hbr, guaifenesin, phenylephrine hcl 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 5mL)                              Purpose

Dextromethorphan HBr, 10 mg ................................. Cough Suppressant

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

Phenylephrine HCl, 5 mg ...................................... Nasal 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 bronchial tubes and make coughs more productive
• nasal congestion
• reduces swelling of nasal passages

WARNINGS

Warnings:

Do no exceed recommended dosage

• A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or a persistent headache, consult a doctor

Do not use this product if you

are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.

Ask a doctor before use if you have

• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
• high blood pressure
• heart disease
• thyroid disease
• diabetes
• difficulty in urincation due to enlargment of the prostate gland unless directed by a doctor

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur

• if symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you are taking sedatives or tranquilizers

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a doctor before use

DOSAGE & ADMINISTRATION

Directions: take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a doctor.

• Age: Dose
• Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 hours
• Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours
• Children under 6 years of age: 1/2 teaspoonful (2.5 mL) every 4 hours to consult a doctor

INACTIVE INGREDIENT

Inactive ingredients: citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, pruified water, sodium citrate, and sucralose.

QUESTIONS

Questions or comments? 1-305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIODESP  DM NF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-263
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)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-263-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2015

Labeler - Advanced Generic Corporation (831762971)