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Name:Notuss Pe
Manufacturer:Sj Pharmaceuticals, Llc
Category:Over-the-counter (OTC) Marketed Drugs


NOTUSS PE

NOTUSS  PE - codeine phosphate and phenylephrine hydrochloride liquid 
SJ 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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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 packaging


Notuss PE packaging


Notuss PE packaging


Notuss PE packaging


Notuss PE packaging


Notuss PE packaging


Notuss PE packaging


NOTUSS   PE
codeine phosphate, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24839-343
Route of Administration ORAL DEA Schedule CV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Codeine Phosphate (Codeine) Codeine Phosphate 10 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine ) Phenylephrine Hydrochloride 10 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor COTTON CANDY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24839-343-10 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE (24839-343-10)
1 NDC:24839-343-10 10 mL in 1 BOTTLE This package is contained within the CARTON (24839-343-10)
2 NDC:24839-343-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/16/2009

Labeler - SJ Pharmaceuticals, LLC (845662720)
Registrant - Great Southern Laboratories (056139553)

Revised: 07/2009 SJ Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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