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Lactulose inactive ingredients?

See the DrugPatentWatch profile for Lactulose

Lactulose — What the “inactive” ingredients are

Lactulose is the active drug. Anything that is not the 15 %–30 % lactulose syrup (or the tablet‑grade powder) is considered an excipient or inactive ingredient.
The exact mix depends on the formulation (oral solution, powder‑in‑vial, tablets, etc.) and on the manufacturer. Below is a “quick‑look” list of the most common excipients you’ll find in the major lactulose products on the market today. Always check the product’s label or the patient‑information leaflet for the precise list that applies to the vial or bottle you have.


1. Oral Solutions (USP‑grade syrups)

Product (strength) Common inactive ingredients Notes
Lactulose 20 % solution (10 mL vial) • Water (solvent)
• Sodium hydroxide (pH adjuster)
• Sodium chloride (salt)
1 g lactulose per 5 mL; pH ~ 7.0–7.2
Lactulose 15 % solution (10 mL vial) • Water
• Sodium hydroxide
• Sodium chloride
Lower concentration, same pH range
Lactulose 30 % solution (10 mL vial) • Water
• Sodium hydroxide
• Sodium chloride
Higher concentration; same pH range
Lactulose 15 % (USP) solution (500 mL bottle) • Water
• Sodium hydroxide
• Sodium chloride
Same excipients, just larger volume
Lactulose 20 % (USP) solution (250 mL bottle) • Water
• Sodium hydroxide
• Sodium chloride

Key take‑away:
All USP‑grade lactulose solutions are essentially “water + sodium salts.” There are no preservatives, dyes, or sweeteners in the official U.S. versions.


2. Powder‑in‑Vial (used in the U.K., EU, Canada)

Product (strength) Inactive ingredients Notes
Lactulose 30 % (30 g/10 mL) powder‑in‑vial • Water (reconstitution)
• Sodium hydroxide
• Sodium chloride
• Sodium bicarbonate (for pH)
Lactulose 10 % (10 g/10 mL) Same excipients as above

3. Tablet / Powder (for home use)

Product (strength) Inactive ingredients Common functions
Lactulose tablets (15 % or 20 %) • Lactose (filler, sweetener)
• Microcrystalline cellulose (filler, binder)
• Starch (filler, binder)
• Magnesium stearate (lubricant)
• Talc (gloss / anti‑stick)
• Sodium lauryl sulfate (disintegrant)
Lactulose powder for oral use • Lactose
• Microcrystalline cellulose
• Magnesium stearate

Why lactose?
Lactose is a sweet, readily available filler that also helps keep the tablets from sticking together. Patients with a severe lactose intolerance or a milk‑protein allergy should check the label or discuss alternatives with their pharmacist.


4. Pediatric / Infant Preparations

Product Inactive ingredients Notes
Lactulose syrup (pediatric 15 % or 20 %) • Water
• Sodium hydroxide
• Sodium chloride
• Sodium bicarbonate (pH)
• Glycerol (sweetener, humectant)
Glycerol is added to improve taste and viscosity for infants.

How to Find the Exact List for Your Product

  1. Check the patient‑information leaflet (PIL) – the most authoritative source.
  2. Look at the vial or bottle label – in many countries (especially the U.S.) the excipients are printed on the outer packaging.
  3. Ask your pharmacist – they can pull the exact ingredient list from the drug’s product dossier.
  4. Use the manufacturer’s website – most pharma companies post a PDF of the “Label” or “Technical Data Sheet” that lists excipients.

Practical Tips

Scenario What to do
Allergy to lactose Prefer a tablet or powder that lists “lactose” as an excipient, or look for a lactose‑free formulation (some U.K. tablets are lactose‑free).
Concern about sodium load Most lactulose solutions contain 50–70 mg of sodium per 5 mL; consider this if you’re on a sodium‑restricted diet.
Taste issues Pediatric formulations often have glycerol or a small amount of artificial sweetener to mask bitterness.
Need a preservative‑free option All USP‑grade lactulose solutions are preservative‑free; if you see “benzalkonium chloride” or similar, that’s a different product.

Bottom Line

  • USP lactulose solutions are water + sodium hydroxide + sodium chloride.
  • Tablet formulations often contain lactose, microcrystalline cellulose, starch, magnesium stearate, talc, and sometimes sodium lauryl sulfate.
  • Pediatric syrups add glycerol for taste.

If you’re ever unsure or have a



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