Dosage form: liquid
Ingredients: Codeine Phosphate 10mg in 5mL, Phenylephrine Hydrochloride 10mg in 5mL
Labeler: SJ Pharmaceuticals, LLC
NDC Code: 24839-343
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.
Active ingredients Purpose
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg ............................. Antitussive
Phenylephrine Hydrochloride 10 mg ................Decongestant
temporary relief of symptoms due to the common cold, hay
fever (allergic rhinitis) or other upper respiratory allergies:
•cough due to minor throat and bronchial irritation • nasal congestion • reduces swelling of the nasal passages
•if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
•a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema •a cough that occurs with too much phlegm (mucus) •chronic pulmonary disease or shortness of breath or children who are taking other drugs •heart disease •high blood pressure •thyroid disease •diabetes mellitus •difficulty in urination due to an enlarged prostate gland
•may cause or aggravate constipation
•nervousness, dizziness, or sleeplessness occur •cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. •new symptoms occur
ask a health professional before use.
In case of an accidental overdose, get medical help or contact a Poison Control Center right away.
|Adults and children 12 years of age and over:||1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period.
|Children 6 to under 12 years of age:||1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in a 24 hour period.
|Children under 6 years of age:||Not recommended for use.
Store at 59° - 86°F (15° - 30°C)
Citric Acid, Cotton Candy Flavor, Glycerin,
Propylene Glycol, Purified Water, Sodium
Citrate, Sodium Saccharin, Sorbitol.
The packaging below represents the labeling currently used.
NDC 24839-343-16 and NDC 24839-343-10
Antitussive - Decongestant
Each 5 mL (one teaspoonful) for oral administration contains:
Codeine Phosphate............ 10 mg
(WARNING: May be habit forming)
Phenylephrine HCl.............. 10 mg
Sugar Free / Alcohol Free
Dye Free / Gluten Free
Cotton Candy Flavor
16 fl. oz. (473 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container with a child-resistant cap.
This bottle not to be dispensed to consumer.
Manufactured by:Great Southern Laboratories
Houston, TX 77099
Distributed for: SJ Pharmaceuticals
4200 Northside Parkway NW, Bldg. 12
Atlanta, GA 30327
Notuss PE Packaging
codeine phosphate, phenylephrine hydrochloride liquid
|Labeler - SJ Pharmaceuticals, LLC (845662720)|
|Registrant - Great Southern Laboratories (056139553)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.