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Gastrocrom (Cromolyn sodium): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current since November 3, 2026
Strength:
20 mg/mL
Drug class:
Active ingredient:
Similar drugs:

Patient information: uses, side effects, how to take - Gastrocrom

How to Use GASTROCROM:

As with all prescription drugs, follow the directions for dosage that your physician recommends.

The effect of GASTROCROM therapy is dependent upon its administration at REGULAR intervals, for as long as recommended by your physician.

Usual Starting Dose:

Adults and Adolescents (13 Years and Older):

Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2-12 Years:

One ampule four times daily, taken one-half hour before meals and at bedtime.

Note:

Your physician may decide to increase OR decrease your dosage to achieve optimum results with GASTROCROM. However, do not change your dose or stop taking GASTROCROM without first consulting your physician.

Care & Storage:

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 (particles or cloudiness) or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready for use.

Recycling Information: GASTROCROM Oral Concentrate ampules are made with a low density polyethylene plastic (recycling material code: LDPE).

Directions for Use:

1.Open foil pouch by tearing at serrated edge as shown.

2.Remove ampule(s) from the strip.

3.Open the ampule by twisting off the tabbed top section.

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

Distributed by:

Meda Pharmaceuticals®

1000 Mylan Blvd

Canonsburg, PA 15317 U.S.A.

GASTROCROM is a registerd trademark of Meda Pharma S.A.R.L., a Viatris Company.

© 2024 Viatris Inc.

Rev. 06/2024

STW-ME7096-642R02

IN-0678-03

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 020479 · View the label on DailyMed

Revision date stated in the text: June 2024

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Gastrocrom

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Mast Cell Stabilizer
Active ingredient Cromolyn sodium 20 mg/mL
Dosage form Liquid
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) VIATRIS SPECIALTY
FDA approval NDA 020479New Drug Application (NDA) Approved February 29, 1996
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code AACodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Drug shortage
  • Current since November 3, 2026
Packages (NDC)
Package
20 mg/mL – 5 ml in 1 ampule / 8 in 1 pouch / 12 in 1 carton NDC 0037-0678-08

Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.