Directions for Use:

Open foil pouch by tearing at serrated edge as shown.

Remove ampule(s) from the strip.

Open the ampule by twisting off the tabbed top section.

Squeeze liquid contents into a glass of water. Stir solution. Drink all of the liquid. Discard the empty ampule.

Marketed by:

Azur Pharma, Inc.
1818 Market Street, Suite 2350

Philadelphia, PA 19103, USA

Manufactured by:
Catalent Pharma Solutions
Woodstock, IL 60098 USA

Gastrocrom® is a registered trademark of
Azur Pharma International Limited©.

© 2010 Azur Pharma International Limited.

Rev. 05/10

GASMp-10-01

PRINICIPAL DISPLAY PANEL - Carton Side and Front Panel

Carton Side and Front

NDC 18860-678-70

Gastrocrom®

(cromolyn sodium, USP)

Oral Concentrate

FOR ORAL USE ONLY -

NOT FOR INHALATION OR INJECTION.

Rx Only

Marketed by:

Azur Pharma, Inc.

1818 Market Street, Suite 2350

Philadelphia, PA 19103, USA.

100 mg/5 mL

96 Plastic Ampules

PRINCIPAL DISPLAY PANEL - Carton Side, Back and Top Panel

Carton Side, Back and Top Panel

Gastrocrom®

(cromolyn sodium, USP)

Oral Concentrate

Manufactured by:
Catalent Pharma Solutions
Woodstock, IL 60098 USA

Gastrocrom® is a registered trademark of
Azur Pharma International Limited©.

© 2010 Azur Pharma International Limited.

DESCRIPTION: Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.

NOTE: See package circular for full prescribing information including contraindications, warnings, and precautions.

GASTROCROM Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready to use.

NDC 18860-678-70

FOR ORAL USE ONLY -

NOT FOR INHALATION OR INJECTION.

Rx Only

Marketed by:

Azur Pharma, Inc.

1818 Market Street, Suite 2350

Philadelphia, PA 19103, USA.

100 mg/5 mL

96 Plastic Ampules

GASTROCROM 
gastrocrom   solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 18860-678
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROMOLYN SODIUM (CROMOLYN)  CROMOLYN SODIUM 20 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
WATER  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 18860-678-70 12 POUCH In 1 CARTON contains a POUCH
1  8 AMPULE In 1 POUCH This package is contained within the CARTON (18860-678-70) and contains a AMPULE
1  5 mL In 1 AMPULE This package is contained within a POUCH and a CARTON (18860-678-70)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Dat