Label: NINJACOF-XG- codeine phosphate liquid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 20, 2014
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
INSTRUCTIONS FOR USE
Directions Take this medication with a full glass of water after each dose to help loosen mucus in the lungs
- Giving a higher dose than recommended by a doctor could result in serious side effects.
Adults and children
12 years of age
2 teaspoonfuls (10mL) every
4 hours, not to exceed
12 teasoonfuls in 24 hours
Children 6 to under
12 years of age:
1 teaspoonful (5 mL) every
4 hours, not to exceed
6 teaspoonfuls in 24 hours
6 years of age:
Consult a doctor.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
16 fl oz (473 mL)
Tamper evident by foil seal under cap. Do not use if foil
seal is broken or missing.
Dispense in a tight, light-resistant container as defined
in the USP/NF with a child-resistant closure.
Store at controlled room temperature,
KEEP THIS AND ALL MEDICATIONS
OUT OF THE REACH OF CHILDREN.
Centurion Labs, LLC Birmingham, AL 35243
INGREDIENTS AND APPEARANCE
codeine phosphate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23359-040 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J) Codeine Phosphate 8 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 mg in 5 mL Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Citrate (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:23359-040-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/20/2014 Labeler - Centurion Labs, LLC (806756461) Registrant - Centurion Labs, LLC (806756461)