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 HBr 10 mg.................. Cough Suppressant

Guaifenesin 187 mg .............................................. Expectorant

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.
  

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.

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. 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

QUESTIONS

Questions or comments? 1-305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOSPEC  DMX
dextromethorphan, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-264
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	187 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-264-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product

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)