Label: GUAIFENESIN AND CODEINE PHOSPHATE solution
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NDC Code(s):
0121-0775-04,
0121-0775-08,
0121-0775-16,
0121-1550-00, view more0121-1550-10, 0121-1550-40, 0121-1775-00, 0121-1775-05, 0121-1775-10, 0121-1775-40
- Packager: PAI Holdings, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 6, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Do not use
- in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.
Ask a doctor before use if you have
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.
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Directions
- take every 4 hours
- do not exceed 6 doses in 24 hours
- a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
- giving a higher dose than recommended by a doctor can result in serious side effects for a child
adults and children 12 years and over 10 mL (2 teaspoonfuls) children 6 to under 12 years of age 5 mL (1 teaspoonful) children under 6 years of age Consult a doctor - Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 0121-0775-16
Guaifenesin and Codeine
Phosphate Oral Solution USP
CV100 mg/10 mg per 5 mL
Expectorant / Cough Suppressant
Alcohol Free / Sugar Free
Each teaspoonful (5 mL) contains:
Guaifenesin, USP 100 mg
Codeine Phosphate, USP 10 mgDispense in a tight, light-resistant
container with a child-resistant closure.DO NOT ACCEPT IF SEAL
AROUND CAP IS BROKEN OR MISSING16 fl oz (473 mL)
pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605 - PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label
- PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label
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INGREDIENTS AND APPEARANCE
GUAIFENESIN AND CODEINE PHOSPHATE
guaifenesin and codeine phosphate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0775 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0775-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2006 2 NDC:0121-0775-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2006 08/02/2023 3 NDC:0121-0775-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/01/2006 GUAIFENESIN AND CODEINE PHOSPHATE
guaifenesin and codeine phosphate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1775 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-1775-00 10 in 1 CASE 10/01/2006 1 10 in 1 TRAY 1 NDC:0121-1775-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:0121-1775-10 10 in 1 CASE 10/01/2006 2 10 in 1 TRAY 2 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC:0121-1775-40 4 in 1 CASE 01/10/2024 3 10 in 1 TRAY 3 NDC:0121-1775-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/01/2006 GUAIFENESIN AND CODEINE PHOSPHATE
guaifenesin and codeine phosphate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1550 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 20 mg in 10 mL Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-1550-00 10 in 1 CASE 10/01/2006 1 10 in 1 TRAY 1 NDC:0121-1550-10 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:0121-1550-40 4 in 1 CASE 01/10/2024 2 10 in 1 TRAY 2 NDC:0121-1550-10 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/01/2006 Labeler - PAI Holdings, LLC (044940096) Establishment Name Address ID/FEI Business Operations PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 097630693 manufacture(0121-0775, 0121-1775, 0121-1550)