Guaifenesin and Codeine Phosphate GUAIFENESIN AND CODEINE PHOSPHATE CARDINAL HEALTH 107, LLC FDA Approved 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
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Substance Codeine Phosphate
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate USP 10 mg Cough Suppressant Guaifenesin USP 100 mg Expectorant
Inactive Ingredients
Inactive ingredients Citric acid edetate disodium FD&C Blue No. 1 FD&C Red No. 40 FD&C Yellow No. 6 flavor glycerin menthol propylene glycol purified water sodium benzoate sodium citrate sodium saccharin and sorbitol.
Strengths
5 ml 10 mg 100 mg
Quantities
5 ml
Treats Conditions
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
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0055154579155
UNII
GSL05Y1MN6 495W7451VQ
Packaging

Principal Display Panel CV NDC 55154-5791-5 GUAIFENESIN AND CODEINE PHOSPHATE ORAL SOLUTION USP 100 mg/10 mg per 5 mL 5 CUPS 100mg/10mg per 5mL bag label

Package Descriptions
  • Principal Display Panel CV NDC 55154-5791-5 GUAIFENESIN AND CODEINE PHOSPHATE ORAL SOLUTION USP 100 mg/10 mg per 5 mL 5 CUPS 100mg/10mg per 5mL bag 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) Overbagged with 5 x 5 mL unit-dose cups in each bag, NDC 55154-5791-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

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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