Dr. Paul Answers Your Questions About Asthma. Watch The Video

Notuss-NX

Generic Name: codeine phosphate and chlorcyclizine hydrochloride
Dosage Form: oral liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Notuss-NX

DESCRIPTION:


Each 5 mL (one teaspoonful) for oral administration contains:
Codeine Phosphate .................................................. 10 mg
(WARNING: May be habit forming)
Chlorcyclizine HCl ............................................... 9.375 mg

Active Ingredients                                                    Purpose

(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg .................................. Antitussive
Chlorcyclizine Hydrochloride 9.375 mg .............. Antihistamine

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

USES:


Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose - sneezing - itching of the nose or throat - itchy, watery eyes - cough due to minor throat and bronchial irritation

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 breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • 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 overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:


Adults and children 12 years of age and older:
2 teaspoonfuls (10 mL) every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period.

Children under 12 years of age:
Consult a doctor

Do not exceed recommended dosage.

PRODUCT PACKAGING:

NOTUSS®-NX

Antitussive-Antihistamine

Each 5 mL (one teaspoonful) for oral administration contains:
Codeine Phosphate .................................................. 10 mg
(WARNING: May be habit forming)
Chlorcyclizine HCl ............................................... 9.375 mg

Rx Only

Sugar Free/Alcohol Free
Dye Free/Gluten Free

Cherry 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

Iss. 08/10
Notuss-NX 
codeine phosphate, chlorcyclizine hcl liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24839-349
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Codeine Phosphate (Codeine) Codeine Phosphate 10 mg  in 5 mL
Chlorcyclizine Hydrochloride (Chlorcyclizine) Chlorcyclizine Hydrochloride 9.375 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Cherry  
Citric Acid  
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Saccharin Sodium  
Sorbitol  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:24839-349-16 473 mL in 1 BOTTLE
2 NDC:24839-349-10 10 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/03/2010
Labeler - SJ PHARMACEUTICALS, LLC (845662720)
Registrant - GREAT SOUTHERN LABORATORIES (056139553)
Establishment
Name Address ID/FEI Operations
GREAT SOUTHERN LABORATORIES 056139553 manufacture
Revised: 12/2011
 
SJ PHARMACEUTICALS, LLC



Hide
(web3)