MAR-COF CG EXPECTORANT- codeine phosphate and guaifenesin syrup

MAR-COF CG by

Drug Labeling and Warnings

MAR-COF CG by is a Otc medication manufactured, distributed, or labeled by Marnel Pharmaceuticals, LLC, Allegis Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each teaspoonful (5 mL))	Purpose
Codeine Phosphate 7.5 mg	Antitussive
Guaifenesin 225 mg	Expectorant

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.

Warnings

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

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

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.

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

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

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

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)

INGREDIENTS AND APPEARANCE

MAR-COF CG   EXPECTORANT
codeine phosphate and guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0682-0475
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	7.5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	225 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0682-0475-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/2008

Labeler - Marnel Pharmaceuticals, LLC (080161449)