Mar-cof ®

Mar-cof ®
SPL v5
SPL
SPL Set ID 60a41229-b125-43d8-b2b4-0bf40feed764
Route
ORAL
Published
Effective Date 2017-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine Anhydrous (7.5 mg) Guaifenesin (225 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-12-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • your cough to help you sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Section 55105-1
Active ingredients (in each teaspoonful (5 mL)) Purpose
Codeine Phosphate 7.5 mg Antitussive
Guaifenesin 225 mg Expectorant
Directions
  • do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over 1 ½ tsp (7.5 mL) every 4-6 hours
Children 6 to under 12 years of age ¾ tsp (3.75 mL) every 4-6 hours
Children under 6 years of age Consult a doctor
Other Information

Each teaspoonful contains 6 mg of sodium. Store at controlled room temperature 15°-30°C (59°-86°F).

Inactive Ingredients

Citric Acid, Flavors, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sorbitol

When Using This Product
  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • may cause or aggravate constipation
Distributed and Marketed By:

Allegis Pharmaceuticals, LLC

276 Nissan Parkway, F100

Canton, MS 39046

Stop Use and Ask A Doctor If
  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
Ask Your Doctor Before Use If
  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs
Principal Display Panel 473 Ml Bottle Label

MARNEL

NDC 0682-0475-16

MAR-COF ®CG



EXPECTORANT

ANTITUSSIVE



(cough suppressant)



EXPECTORANT

Each 5mL (one teaspoonful) for oral



administration contains:

Codeine Phosphate 7.5 mg



Guaifenesin 225 mg

Alcohol-Free / Sugar-Free

TAMPER EVIDENT:



Do not use if imprinted safety seal

under cap is broken or missing.

16 fl. oz. (473 mL)


Structured Label Content

Uses
  • temporarily relieves
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • your cough to help you sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each teaspoonful (5 mL)) Purpose
Codeine Phosphate 7.5 mg Antitussive
Guaifenesin 225 mg Expectorant
Directions
  • do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over 1 ½ tsp (7.5 mL) every 4-6 hours
Children 6 to under 12 years of age ¾ tsp (3.75 mL) every 4-6 hours
Children under 6 years of age Consult a doctor
Other Information (Other information)

Each teaspoonful contains 6 mg of sodium. Store at controlled room temperature 15°-30°C (59°-86°F).

Inactive Ingredients (Inactive ingredients)

Citric Acid, Flavors, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sorbitol

When Using This Product (When using this product)
  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • may cause or aggravate constipation
Distributed and Marketed By:

Allegis Pharmaceuticals, LLC

276 Nissan Parkway, F100

Canton, MS 39046

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
Ask Your Doctor Before Use If (Ask your doctor before use if)
  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

MARNEL

NDC 0682-0475-16

MAR-COF ®CG



EXPECTORANT

ANTITUSSIVE



(cough suppressant)



EXPECTORANT

Each 5mL (one teaspoonful) for oral



administration contains:

Codeine Phosphate 7.5 mg



Guaifenesin 225 mg

Alcohol-Free / Sugar-Free

TAMPER EVIDENT:



Do not use if imprinted safety seal

under cap is broken or missing.

16 fl. oz. (473 mL)


Advanced Ingredient Data


Raw Label Data

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