Label: CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution
- NDC Code(s): 69367-272-04, 69367-272-16
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- 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.
Drug Label Information
Updated January 10, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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.
- Other information
- Inactive Ingredients
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
10-100 mg/5 mL
Sugar Free, Alcohol Free, Dye Free
Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP
(WARNING: May be habit-forming)
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
16 fl. oz. (473 mL)
INGREDIENTS AND APPEARANCE
codeine phosphate and guaifenesin solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69367-272 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 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69367-272-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2020 2 NDC:69367-272-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/15/2020 Labeler - Westminster Pharmaceuticals, LLC (079516651)