NOTUSS-NXD- codeine phosphate, pseudoephedrine hcl, chlorcyclizine hcl liquid 
SJ PHARMACEUTICALS, LLC

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-NXD

DESCRIPTION:

Each 5 mL (one teaspoonful) for oral administration contains:
Codeine Phosphate .................................................. 10 mg
(WARNING: May be habit forming)
Pseudoephedrine HCl .............................................. 30 mg
Chlorcyclizine HCl ............................................... 9.375 mg

Active Ingredients                                                    Purpose
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg .................................. Antitussive
Pseudoephedrine Hydrochloride 30 mg ........... Decongestant
Chlorcyclizine Hydrochloride 9.375 mg .............. Antihistamine

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 - 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 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 occurs
  • 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®-NXD

Antitussive - Decongestant - Antihistamine

Each 5 mL (one teaspoonful) for oral administration contains:
Codeine Phosphate .................................................. 10 mg
(WARNING: May be habit forming)
Pseudoephedrine HCl .............................................. 30 mg
Chlorcyclizine HCl ............................................... 9.375 mg

Rx Only

Sugar Free/Alcohol Free
Dye Free/Gluten Free

Berry Vanilla 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-NXD Packaging
Notuss-NXD Packaging
NOTUSS-NXD 
codeine phosphate, pseudoephedrine hcl, chlorcyclizine hcl liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24839-348
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) Codeine Phosphate10 mg  in 5 mL
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Chlorcyclizine Hydrochloride (UNII: NPB7A7874U) (Chlorcyclizine - UNII:M26C4IP44P) Chlorcyclizine Hydrochloride9.375 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Berry (UNII: FV3431923Z)  
Vanilla (UNII: Q74T35078H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24839-348-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/201008/18/2012
2NDC:24839-348-1010 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/201008/18/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/03/201008/18/2012
Labeler - SJ PHARMACEUTICALS, LLC (845662720)
Registrant - GREAT SOUTHERN LABORATORIES (056139553)

Revised: 9/2017
 
SJ PHARMACEUTICALS, LLC