Codeine-Guaifenesin CODEINE PHOSPHATE AND GUAIFENESIN METHOD PHARMACEUTICALS, LLC FDA Approved Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.
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Substance Codeine Phosphate
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each teaspoonful (5 mL)) Codeine Phosphate USP 10 mg Active ingredient (in each teaspoonful (5 mL)) Guaifenesin USP 100 mg
Inactive Ingredients
Inactive ingredients Cherry Flavor Citric Acid Glycerin Masking flavor Propylene glycol Purified Water Sodium Citrate Sodium Benzoate Sucralose Sorbitol.
Strengths
5 ml 10 mg 100 mg
Quantities
5 ml 473 ml
Treats Conditions
Uses Temporarily Relieves Cough Due To Minor Throat And Bronchial Irritation As May Occur With A Cold Or Inhaled Irritants Your Cough To Help You Sleep Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Makes Cough More Productive

Identifiers & Packaging

Container Type UNKNOWN
UNII
GSL05Y1MN6 495W7451VQ
Packaging

Principal Display Panel NDC 58657-500-16 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant 16 fl. oz. (473 mL) label

Package Descriptions
  • Principal Display Panel NDC 58657-500-16 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant 16 fl. oz. (473 mL) label

Overview

Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.

Indications & Usage

Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.

Dosage & Administration

Directions do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

Warnings & Precautions
Warnings Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs When using this product 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. may cause or aggravate constipation Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Antitussive Purpose Expectorant

When Using

When using this product 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. may cause or aggravate constipation

Stop Use & Ask a Doctor

Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other information Store at controlled room temperature 15°-30°C (59°-86°F).


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