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Z-COF

Pernix Therapeutics

Z-Cof™ 12 DM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 15 mg Cough Suppressant
Guaifenesin 175 mg Expectorant
Pseudoephedrine HCl 30 mg Nasal Decongestant

Z-COF 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

Do not exceed recommended dosage.

Do not use this product

  • 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

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accompanied by too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop Use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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. 800-222-1222

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and older: 2 teaspoonfuls (10 mL) every 8 hours, not to exceed 6 teaspoonfuls in 24 hours
Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 8 hours, not to exceed 3 teaspoonfuls in 24 hours
Children under 6 years of age: Consult a doctor

Other Information

Store at 59°-86°F (15°-30°C).

Inactive ingredients

Bitter Mask, Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions? Comments?

Call 1-800-793-2145

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 65224-615-16

Z-Cof
12
DM

No Antihistamine • Alcohol Free

Cough Suppressant, Expectorant, Nasal Decongestant

GRAPE FLAVOR

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

Dextromethorphan Hydrobromide 15 mg
Guaifenesin 175 mg
Pseudoephedrine Hydrochloride 30 mg

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.
Dispense in a tight, light-resistant container with a child-resistant cap.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

16 fl. oz. (473 mL)

MANUFACTURED FOR:
PERNIX

THERAPEUTICS
Magnolia, TX 77354
Rev. 11/11

Z-COF

Z-COF

PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN, and DEXTROMETHORPHAN HYDROBROMIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65224-615
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg
Guaifenesin GUAIFENESIN 175 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
FD&C BLUE NO. 1
FD&C RED NO. 40
GRAPE
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65224-615-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-11-17


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Be sure to consult your doctor before taking any medication!
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