NOTUSS PE

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.

NOTUSS PE

Drug Facts


Active ingredients          Purpose
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg ............................. Antitussive
Phenylephrine Hydrochloride 10 mg ................Decongestant

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

Warnings Do not exceed recommended dosage

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.

Ask a doctor before use if you have

•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

When using this product

•may cause or aggravate constipation

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children

In case of an accidental overdose, get medical help or contact a Poison Control Center right away.

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.

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Citric Acid, Cotton Candy Flavor, Glycerin,
Propylene Glycol, Purified Water, Sodium
Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Call 1-877-604-7575

Rx Only

CV

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
codeine phosphate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24839-343
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine) Codeine Phosphate10 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine ) Phenylephrine Hydrochloride10 mg  in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:24839-343-101 BOTTLE (BOTTLE) in 1 CARTON
1NDC:24839-343-1010 mL in 1 BOTTLE
2NDC:24839-343-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/16/2009
Labeler - SJ Pharmaceuticals, LLC (845662720)
Registrant - Great Southern Laboratories (056139553)

Revised: 07/2009
 
SJ Pharmaceuticals, LLC

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.

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