Z-COF 1 description, usages, side effects, indications, overdosage, supplying and lots more!

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Z-COF 1

Pernix Therapeutics, LLC

Z-Cof™ 1


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
Pseudoephedrine HCl 30 mg Decongestant
Guaifenesin 211 mg Expectorant

Z-COF 1 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 older 2 teaspoonfuls
Children 6 to under 12 years of age 1 teaspoonful
Children under 6 years of age Ask 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 Hydrobromide 15mg
Pseudoephedrine Hydrochloride 30mg
Guaifenesin 211mg

Shake well

16 fl. oz. (473 mL)

Z-COF 1

Z-COF 1

DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and GUAIFENESIN SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65224-618
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg
Guaifenesin GUAIFENESIN 211 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65224-618-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-05-02


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Be sure to consult your doctor before taking any medication!
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