BIO-Z-COUGH- dextromethorphan hydrobromide, guaifenesin liquid

Bio-Z-Cough by

Drug Labeling and Warnings

Bio-Z-Cough 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 tps.)                               Purpose

Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant

Guaifenesin.... 400 mg........................................................Expectorant

PURPOSE

Uses:

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
  

WARNINGS

Warnings:

Ask a doctor before use if you have:

• cough that occurs with too much phlegm (mucus)
  

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

When using this product do not use more than directed.

Stop use and ask a doctor before use 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.
  

DO NOT USE

Do not use:

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs of 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 MAOI; ask your doctor or pharmacist before taking this product.

KEEP OUT OF REACH OF CHILDREN

Keep out of the 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

Direction: do not exceed more than 6 doses in any 24 hours period.

• Adults and children 12 years of age and over.: Take 1 teaspoonful (5 mL) every 4 hours
• Children under 12 years of age.: Consult a physician

INDICATIONS & USAGE

Other Information:

• Store at room temperature 15 - 30 degrees celsius (59 - 86 degrees farenheit)
• Tamper evident feature Do not use if seal under cap is torn, broken or missing.
• Avoid excessive heat or humidity.
  

INACTIVE INGREDIENT

Inactive Ingredients:

Citric Acid, eucalyptus oil, menthol, methylparaben, propylparaben, propylene glycol, sodium citrate, polyethylene glycol, grape flavor, sucralose, and purified 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

BIO-Z-COUGH 
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-251
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: 45737-251-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2012

Labeler - Advanced Generic Corporation (831762971)