BIOSPEC DMX- dextromethorphan, guaifenesin liquid

Biospec by

Drug Labeling and Warnings

Biospec 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 25 mg .............................................. Expectorant

PURPOSE

Uses

• temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs 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.
  

DO NOT USE

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or accompanied by fever
• 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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions Do not take more than 6 doses in any 24-hour period, unless directed by a physician

adults and children 12 years and over, 1 teaspoonfuls (5 ml) every 4 hours

children 6 years to under 12 years, 1/2 teaspoonful (2.5 ml) every 4 hours

children 4 to 6 years, 1/4 teaspoonful (1.25 ml) every 4 hours

children under 4 years of age, consult 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.

INACTIVE INGREDIENT

Inactive ingredients Cherry Flavor, Glycerin, Menthol, Potassium Guaiacol Sulfonate,
Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Water.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOSPEC  DMX
dextromethorphan, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-211
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	25 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Menthol (UNII: L7T10EIP3A)
Water (UNII: 059QF0KO0R)
POTASSIUM GUAIACOLSULFONATE (UNII: TTK33Z47F1)
Glycerin (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
Sodium Citrate (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-211-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2009

Labeler - Advanced Generic Corporation (831762971)