NDC | 0682-0475-16 |
Set ID | 60a41229-b125-43d8-b2b4-0bf40feed764 |
Category | HUMAN OTC DRUG LABEL |
Packager | Marnel Pharmaceuticals, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
- Directions
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
MARNEL
NDC 0682-0475-16
MAR-COF ®CG
EXPECTORANTANTITUSSIVE
(cough suppressant)
EXPECTORANTEach 5mL (one teaspoonful) for oral
administration contains:Codeine Phosphate 7.5 mg
Guaifenesin 225 mgAlcohol-Free / Sugar-Free
TAMPER EVIDENT:
Do not use if imprinted safety seal
under cap is broken or missing.16 fl. oz. (473 mL)
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INGREDIENTS AND APPEARANCE
MAR-COF CG EXPECTORANT
codeine phosphate and guaifenesin syrupProduct 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)