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What Is Hyosyne?

Hyosyne is an oral hyoscyamine sulfate product with anticholinergic and antispasmodic activity. Oral drops contain 0.125 mg per mL and the elixir contains 0.125 mg per 5 mL. Current DailyMed listings classify Hyosyne as an unapproved drug, and the product does not have FDA approval.

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What Is Hyosyne?

Hyosyne is an oral hyoscyamine sulfate product with anticholinergic and antispasmodic activity. Oral drops contain 0.125 mg per mL and the elixir contains 0.125 mg per 5 mL. Current DailyMed listings classify Hyosyne as an unapproved drug, and the product does not have FDA approval.

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How Does Hyosyne Work?

Hyoscyamine blocks acetylcholine activity at peripheral cholinergic receptors. This decreases gastrointestinal motility and gastric acid secretion, reduces excessive respiratory secretions, and relaxes selected smooth muscle. It also crosses the blood-brain barrier and can cause central anticholinergic effects.

What Uses Are Described for Hyosyne?

Current unapproved labeling describes adjunctive use for peptic ulcer, irritable bowel syndrome, gastrointestinal and bladder spasm, cystitis, neurogenic bowel or bladder disorders, biliary or renal colic, and selected other anticholinergic uses. The drops and elixir labeling also describes use for infant colic.

How Is Hyosyne Dosed?

For Hyosyne oral drops, adults and patients age 12 and older take 1 to 2 mL every four hours as needed, with no more than 12 mL daily. The elixir uses 1 to 2 teaspoonfuls every four hours as needed, with no more than 12 teaspoonfuls daily. Younger pediatric dosing is weight based.

What Safety Concerns Apply to Hyosyne?

Hyosyne can cause drowsiness, dizziness, blurred vision, dry mouth, urinary retention, constipation, rapid heart rate, confusion, and reduced sweating. Heat prostration can occur in high temperatures. Current labeling lists glaucoma, obstructive urinary or gastrointestinal disease, paralytic ileus, severe ulcerative colitis, toxic megacolon, and myasthenia gravis among the contraindications.

Frequently Asked Questions About Hyosyne

What medicine is in Hyosyne?

Hyosyne contains hyoscyamine sulfate, an anticholinergic and antispasmodic belladonna alkaloid.

What strength are Hyosyne oral drops?

The oral drops contain 0.125 mg of hyoscyamine sulfate per mL.

What strength is Hyosyne elixir?

The elixir contains 0.125 mg of hyoscyamine sulfate per 5 mL.

Is Hyosyne FDA approved?

No. Current DailyMed listings classify Hyosyne as an unapproved drug and state that the product does not have FDA approval.

References

DailyMed - HYOSYNE (hyoscyamine sulfate) elixir. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0e8f7d7-9316-4b78-acc8-17519b9b3165. Date Accessed October 1, 2026.

DailyMed - HYOSYNE (hyoscyamine sulfate) solution/drops. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38f12473-08e0-4970-a6ef-a825cc7de8d8. Date Accessed October 1, 2026.

Hyoscyamine. LiverTox. https://www.ncbi.nlm.nih.gov/books/NBK548870/. Date Accessed October 1, 2026.

Hyoscyamine. MedlinePlus. https://www.medlineplus.gov/druginfo/meds/a684010.html. Date Accessed October 1, 2026.

Hyoscyamine Sulfate. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Hyoscyamine-Sulfate. Date Accessed October 1, 2026.