Colcrys Recall

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Questions & Answers

Side Effects & Adverse Reactions

In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.

Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation and mannerisms and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Tablets, USP are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.


There is currently no drug history available for this drug.

Other Information

Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration.

Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2•H2SO4•2H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:

Molecular Structure of Hyoscyamine sulfate

Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.

Colcrys Manufacturers

  • Proficient Rx Lp
    Colcrys (Colchicine) Tablet, Film Coated [Proficient Rx Lp]
  • Physicians Total Care, Inc.
    Colcrys (Colchicine) Tablet, Film Coated [Physicians Total Care, Inc.]
  • Ar Scientific Inc.
    Colcrys (Colchicine) Tablet, Film Coated [Ar Scientific Inc.]
  • Remedyrepack Inc.
    Colcrys (Colchicine) Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Colcrys (Colchicine) Tablet, Film Coated [Remedyrepack Inc. ]
  • Takeda Pharmaceuticals America, Inc.
    Colcrys (Colchicine) Tablet, Film Coated [Takeda Pharmaceuticals America, Inc.]
  • Aphena Pharma Solutions – Tennessee, Llc
    Colcrys (Colchicine) Tablet, Film Coated [Aphena Pharma Solutions – Tennessee, Llc]
  • Cardinal Health
    Colcrys (Colchicine) Tablet, Film Coated [Cardinal Health]

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