Z-COF 1

Dosage form: suspension
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL, GUAIFENESIN 211mg in 5mL
Labeler: Pernix Therapeutics, LLC
NDC Code: 65224-618

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Z-Cof™ 1

Drug Facts

Active ingredients (in each 5 mL)Purpose
Dextromethorphan HBr 15 mgCough Suppressant
Pseudoephedrine HCl 30 mgDecongestant
Guaifenesin 211 mgExpectorant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep
  • nasal congestion due to the common cold
  • promotes nasal and/or sinus drainage

Warnings

  • may cause excitability, or increased irritability especially in children

  • 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble with urination due to enlargement of the prostate gland
  • cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions
  • take every 8 hours
  • do not take more than 3 doses in 24 hours or as directed by a doctor
Adults and children 12 years of age and older2 teaspoonfuls
Children 6 to under 12 years of age1 teaspoonful
Children under 6 years of ageAsk a doctor

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)

  • Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Acesulfame K, Artificial Grape Flavor, Aspartame, Bitter Mask, Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Methylparaben, Magnesium Aluminometasilicate, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Xanthan Gum.

Questions?

Call 1-800-793-2145

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 65224-618-16

PERNIX
THERAPEUTICS

Z-Cof 1

Antitussive/Decongestant/
Expectorant

GRAPE FLAVOR

Alcohol Free

Each 5 mL (one teaspoonful) for oral administration
contains:

Dextromethorphan Hydrobromide15mg
Pseudoephedrine Hydrochloride30mg
Guaifenesin211mg

Shake well

16 fl. oz. (473 mL)

Z-COF 1 
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and guaifenesin suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65224-618
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN211 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
GRAPE 
ASPARTAME 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
METHYLPARABEN 
MAGNESIUM ALUMINUM SILICATE 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
XANTHAN GUM 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65224-618-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/02/2011
Labeler - Pernix Therapeutics, LLC (004672296)

Revised: 04/2011
 
Pernix Therapeutics, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)