NDC Code(s) : 24839-348-16, 24839-348-10
Packager : SJ PHARMACEUTICALS, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Notuss-NXD Codeine Phosphate, Pseudoephedrine HCl, Chlorcyclizine HCl LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24839-348
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Codeine Phosphate(UNII: GSL05Y1MN6)
(Codeine - UNII:Q830PW7520) 		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 Name Strength
Berry(UNII: FV3431923Z)
Vanilla(UNII: Q74T35078H)
Citric Acid(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
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24839-348-16473 mL in 1 BOTTLE
2NDC:24839-348-1010 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

PRINCIPAL DISPLAY PANEL

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 PackagingNotuss-NXD Packaging