Cromolyn Sodium Solution/ Drops label

Cromolyn Sodium Solution/ Drops

Cromolyn Sodium Solution/ Drops Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Cromolyn sodium ophthalmic solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

History

There is currently no drug history available for this drug.

Other Information

Cromolyn sodium ophthalmic solution USP, 4% is a clear, colorless, sterile solution for topical ophthalmic use.

Cromolyn sodium is represented by the following structural formula:

cromolyn sodium (structural formula)

C23H14Na2O11 Mol. Wt. 512.34

Chemical Name: Disodium 5,5′- [(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]

Pharmacologic Category: Mast cell stabilizer.

EACH mL CONTAINS: ACTIVE: Cromolyn Sodium 40 mg (4%); INACTIVES: Edetate Disodium 0.1% and Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 – 7.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

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Cromolyn Sodium Solution/ Drops Recall

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Cromolyn Sodium Solution/ Drops Manufacturers

Proficient Rx Lp
No Recall
Cromolyn Sodium Solution/ Drops | Proficient Rx Lp
The dose is 1 – 2 drops in each eye 4 – 6 times a day at regular intervals.

One drop contains approximately 1.6 mg cromolyn sodium.

Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.

Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution.

FOR OPHTHALMIC USE ONLY
Bausch & Lomb Incorporated
No Recall
Cromolyn Sodium Solution/ Drops | Bausch & Lomb Incorporated
The dose is 1 – 2 drops in each eye 4 – 6 times a day at regular intervals.

One drop contains approximately 1.6 mg cromolyn sodium.

Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.

Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution.

FOR OPHTHALMIC USE ONLY
Akorn, Inc.
No Recall
Cromolyn Sodium Solution/ Drops | Rxchange Co.
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Teva Pharmaceuticals Usa Inc.
No Recall
Cromolyn Sodium Solution/ Drops | Teva Pharmaceuticals Usa Inc.
The dose is 1 – 2 drops in each eye 4 – 6 times a day at regular intervals.

One drop contains approximately 1.6 mg cromolyn sodium.

Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.

Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution.

FOR OPHTHALMIC USE ONLY.
Sandoz Inc
No Recall
Cromolyn Sodium Solution/ Drops | Sandoz Inc
The dose is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium.

Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.

Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

If required, corticosteroids may be used concomitantly with Cromolyn Sodium Ophthalmic Solution USP, 4%.