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FDA Information

Famotidine was approved by the FDA in 1995, and is available either with or without a prescription.

Note: in Oct. 2005, the FDA approved revisions to the safety labeling for famotidine chewable tablets, Gelcaps®, the original and maximum strength film-coated tablets (Pepcid AC®, made by Merck), and famotidine/calcium carbonate/magnesium hydroxide tablets (Pepcid Complete®, made by Merck) to warn of contraindications associated with their over-the-counter use.

Famotidine should not be used in patients experiencing difficult or painful swallowing, vomiting with blood, or bloody or tarry stools. These may be signs of a serious condition and should be evaluated by a physician.

Additionally, the FDA notes that famotidine should not be used concurrently with other acid reducers.


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