NOTUSS PE Codeine Phosphate, Phenylephrine Hydrochloride Codeine Phosphate CODEINE ANHYDROUS Phenylephrine Hydrochloride Phenylephrine GLYCERIN
Drug Facts
Composition & Profile
Identifiers & Packaging
PRODUCT PACKAGING The packaging below represents the labeling currently used. NDC 24839-343-16 and NDC 24839-343-10 NOTUSS-PE Antitussive - Decongestant Each 5 mL (one teaspoonful) for oral administration contains: Codeine Phosphate............ 10 mg (WARNING: May be habit forming) Phenylephrine HCl.............. 10 mg Rx Only Sugar Free / Alcohol Free Dye Free / Gluten Free Cotton Candy Flavor 16 fl. oz. (473 mL) SJ Pharmaceuticals 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 Iss. 06/09 Notuss PE Packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging
- PRODUCT PACKAGING The packaging below represents the labeling currently used. NDC 24839-343-16 and NDC 24839-343-10 NOTUSS-PE Antitussive - Decongestant Each 5 mL (one teaspoonful) for oral administration contains: Codeine Phosphate............ 10 mg (WARNING: May be habit forming) Phenylephrine HCl.............. 10 mg Rx Only Sugar Free / Alcohol Free Dye Free / Gluten Free Cotton Candy Flavor 16 fl. oz. (473 mL) SJ Pharmaceuticals 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 Iss. 06/09 Notuss PE Packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging Notuss PE packaging
Overview
Drug Facts Active ingredients Purpose (in each 5 mL teaspoonful) Codeine Phosphate 10 mg ............................. Antitussive Phenylephrine Hydrochloride 10 mg ................ Decongestant
Indications & Usage
Uses 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
Dosage & Administration
Directions Do not exceed recommended dosage. 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.
Warnings & Precautions
Warnings Do not exceed recommended dosage
Purpose
Uses 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
Do Not Use
Do not use this product •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.
When Using
When using this product •may cause or aggravate constipation
Stop Use & Ask a Doctor
Stop use and ask a doctor if •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
Keep Out of Reach of Children
Keep out of the reach of children In case of an accidental overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other information Store at 59° - 86°F (15° - 30°C)
Questions
Questions? Comments? Call 1-877-604-7575 Rx Only CV
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