Label: CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution
- NDC Code(s): 71205-624-04
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 69367-272
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
Drug Label Information
Updated October 1, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Ask your doctor before use if
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- you have a persistent cough, this may be a sign of a serious condition
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- you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
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- you have a cough that is accompanied by excessive phlegm (mucus)
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- you have chronic pulmonary disease or shortness of breath
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- giving to a child who is taking other drugs
When using this product
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- 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.
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- may cause or aggravate constipation
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
CODEINE-GUAIFENESIN
codeine phosphate and guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-624(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) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-624-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/15/2020 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(71205-624)