Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL GUAIFENESIN GUAIFENESIN CODEINE PHOSPHATE CODEINE ANHYDROUS
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL DRUG: Guaifenesin and Codeine Phosphate GENERIC: Guaifenesin and Codeine Phosphate DOSAGE: SOLUTION ADMINSTRATION: ORAL NDC: 70518-2434-0 COLOR: red FLAVOR: CHERRY PACKAGING: 118 mL in 1 BOTTLE ACTIVE INGREDIENT(S): GUAIFENESIN 100mg in 5mL CODEINE PHOSPHATE 10mg in 5mL INACTIVE INGREDIENT(S): CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL Remedy_Label
- PRINCIPAL DISPLAY PANEL DRUG: Guaifenesin and Codeine Phosphate GENERIC: Guaifenesin and Codeine Phosphate DOSAGE: SOLUTION ADMINSTRATION: ORAL NDC: 70518-2434-0 COLOR: red FLAVOR: CHERRY PACKAGING: 118 mL in 1 BOTTLE ACTIVE INGREDIENT(S): GUAIFENESIN 100mg in 5mL CODEINE PHOSPHATE 10mg in 5mL INACTIVE INGREDIENT(S): CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL Remedy_Label
Overview
Uses temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Indications & Usage
Uses temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Dosage & Administration
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
Warnings & Precautions
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. Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age.
Purpose
Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant
Do Not Use
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.
Stop Use & Ask a Doctor
Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation
Keep Out of Reach of Children
Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age.
Storage & Handling
Other information Sodium Content: 5 mg/5 mL Tamper evident: Do not use if seal under cap is broken or missing Keep container closed and store away from heat Store at 20°- 25°C (68°-77°F)
Questions
Questions or comments? Call 1-800-845-8210 or visit paipharma.com Serious side effects associated with use of this product may be reported to this number.
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