GUAIFENESIN AND CODEINE PHOSPHATE solution
Guaifenesin and Codeine Phosphate by
Drug Labeling and Warnings
Guaifenesin and Codeine Phosphate by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- 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 are taking 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
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PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label
Delivers 10 mL
NDC: 0121-1550-10
G UAIFENESIN AND
C ODEINE P HOSPHATE
O RAL S OLUTION USP
CV
200 mg/20 mg per 10 mL
Expectorant / Cough Suppressant
Alcohol Free / Sugar Free
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
A17751001
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PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label - 1775
Delivers 10 mL
NDC: 0121-1775-10
G UAIFENESIN AND
C ODEINE P HOSPHATE
O RAL S OLUTION USP
CV200 mg/20 mg per 10 mL
Expectorant / Cough Suppressant
Alcohol Free / Sugar FreeFOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERTA17751000
-
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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) 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 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 final part341 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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) 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 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 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/01/2006 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0775, 0121-1775, 0121-1550)
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