GUAIFENESIN AND CODEINE PHOSPHATE- guaifenesin and codeine phosphate solution
QUAGEN PHARMACEUTICALS LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Active ingredients (in each 5 mL = 1 tsp)
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Purpose
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Codeine phosphate, USP 10 mg
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Cough suppressant
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Guaifenesin, USP 100 mg
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Expectorant
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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 make coughs more productive.
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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- Do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over:
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2 tsp (10 mL) every 4 hours, or as directed by a doctor.
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Children 6 to under 12 years of age:
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1 tsp (5 mL) every 4 hours,
or as directed by a doctor.
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Children under 6 years of age:
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Consult a doctor.
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Other information
Each tsp (5 mL) contains 3 mg sodium.
Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.
Inactive ingredients
Alcohol, caramel flavor, cherry flavor, citric acid, FD&C Red #40, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006
MADE IN USA
PRINCIPAL DISPLAY PANEL-4 fl oz (118 mL) Container Label
PRINCIPAL DISPLAY PANEL-8 fl oz (237 mL) Container Label
PRINCIPAL DISPLAY PANEL-16 fl oz (473 mL) Container Label