Medication-info.com Search Menu

Cromolyn (Gastrocrom): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current since November 2, 2026
Strength:
100 mg/5 mL
Brand names:
Drug class:
Active ingredient:
Similar drugs:

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

How to Use Cromolyn Sodium Oral Solution (Concentrate):

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

The effect of Cromolyn Sodium Oral Solution (Concentrate) 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 Cromolyn Sodium Oral Solution (Concentrate). However, do not change your dose or stop taking Cromolyn Sodium Oral Solution (Concentrate) without first consulting your physician.

Care & Storage:

Cromolyn Sodium Oral Solution (Concentrate) should be stored between 20° - 25°C (68° - 77°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: Cromolyn Sodium Oral Solution (Concentrate) ampules are made with a low density polyethylene plastic (recycling material code: LDPE).

Call your doctor for medical advice about side effects. You may report side effects to Omnivium Pharmaceuticals LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch..

Directions for Use:
  1. 1. Open foil

pouch by tearing

at serrated edge as

shown.

  1. 2. Remove

ampule(s) from

the strip.

  1. 3. Open the ampule

by twisting off the

tabbed top section.

  1. 4. Squeeze liquid

contents into a glass

of water. Stir

solution. Drink all

of the liquid.

Discard the empty ampule.

Marketed by:

Omnivium Pharmaceuticals LLC

Rahway, NJ 07065

Rev.: May 2024

RPIN0198

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 209264 · View the label on DailyMed

Revision date stated in the text: May 2024

Found a mistake? Write to us via the contact page.

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

Drug information for Cromolyn

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 100 mg/5 mL
Dosage form Solution, concentrate
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) AILEX PHARMS LLC
FDA approval ANDA 209264Abbreviated New Drug Application (ANDA) – generic drug Approved October 16, 2017
Therapeutic equivalence (TE) code AACodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 6 labelers list this drug on DailyMed
Drug shortage
  • Current since November 2, 2026
Packages (NDC)
Package
100 mg/5 mL – 5 ml in 1 ampule / 8 in 1 pouch / 12 in 1 carton NDC 81665-104-96

Source: FDA drug labeling via NLM DailyMed, data as of November 4, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.