Lactulose
20 g/30mL · Solution
- Prescription only
- Osmotic Laxative
- Active substance
- Lactulose
- Made by
- PAI Holdings, LLC dba PAI Pharma
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-09-15
Osmotic Laxative
- For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily.
Full directions ↓Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
From the official label · 2025-09-15 · DailyMed
How it works
From this product’s own US prescribing label.
Lactulose is poorly absorbed from the gastrointestinal tract, and no enzyme capable of hydrolysis of this disaccharide is present in human gastrointestinal tissue.
As a result, oral doses of lactulose solution reach the colon virtually unchanged.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-09-15
Do not take it if
Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily.
- The dose may be increased to 60 mL daily if necessary.
- Twenty-four to 48 hours may be required to produce a normal bowel movement.
- Note:
- Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water or milk.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- A theoretical hazard may exist for patients being treated with lactulose solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy.
- Accumulation of H 2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction.
- Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution.
- Insufflation of CO 2 as an additional safeguard may be pursued but is considered to be a redundant measure.
- General Since lactulose solution contains galactose (less than1.6 g/15 mL) and lactose (less than 1.2 g/15 mL), it should be used with caution in diabetics.
- Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician.
- Laboratory Tests Elderly, debilitated patients who receive lactulose solution for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.
- Drug Interactions Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH.
- Carcinogenesis, Mutagenesis, Impairment of Fertility There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.
- There are no known animal data on long-term potential for mutagenicity.
- Administration of lactulose solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (V/W) did not produce any evidence of carcinogenicity.
- In studies in mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition.
- Pregnancy:Teratogenic Effects.
- Nursing Mothers It is not known whether this drug is excreted in human milk.
- Pediatric Use Safety and effectiveness in pediatric patients have not been established.
- General Since lactulose solution contains galactose (less than1.6 g/15 mL) and lactose (less than 1.2 g/15 mL), it should be used with caution in diabetics.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects.
- Pregnancy Category B:
- Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose.
- There are, however, no adequate and well-controlled studies in pregnant women.
- Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH.
- Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose solution.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- Signs and Symptoms There have been no reports of accidental overdosage.
- In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms.
- Medication should be terminated.
- Oral LD 50 The acute oral LD 50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats.
- Dialysis Dialysis data are not available for lactulose.
- Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.
Quoted from the official label, section “Overdosage”.
Use in children
Safety and effectiveness in pediatric patients have not been established.
Quoted from the official label, section “Pediatric Use”.
Side effects
- Precise frequency data are not available.
- Initial dosing may produce flatulence and intestinal cramps, which are usually transient.
- Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia.
- Nausea and vomiting have been reported.
- To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
In the event that an unusual diarrheal condition occurs, contact your physician.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- NDC 0121-0577-08:
- 8 fl oz (237 mL) bottles NDC 0121-0577-16:
- 16 fl oz (473 mL) bottles NDC 0121-0577-32:
- 32 fl oz (946 mL) bottle NDC 0121-4577-15:
- 15 mL unit dose cup NDC 0121-4577-40:
- Case contains 40 unit dose cups of 15 mL (0121-4577-15) packaged in 4 trays of 10 unit dose cups each.
- NDC 0121-4577-06:
- Case contains 96 unit dose cups of 15 mL (0121-4577-15) packaged in 6 cartons of 16 unit dose cups each.
- NDC 0121-1154-30:
- 30 mL unit dose cup NDC 0121-1154-40:
- Case contains 40 unit dose cups of 30 mL (0121-1154-30) packaged in 4 trays of 10 unit dose cups each.
- NDC 0121-1154-00:
- Case contains 100 unit dose cups of 30 mL (0121-1154-30) packaged in 10 trays of 10 unit dose cups each.
- NDC 0121-1154-06:
- Case contains 96 unit dose cups of 30 mL (0121-1154-30) packaged in 6 cartons of 16 unit dose cups each.
- Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL).
- Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Do not freeze.
- Under recommended storage conditions, a normal darkening of color may occur.
- Such darkening is characteristic of sugar solutions and does not affect therapeutic action.
- Prolonged exposure to temperatures above 30°C (86°F) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable.
- If this condition develops, do not use.
- Prolonged exposure to freezing temperatures may cause change to a semisolid, too viscous to pour.
- Viscosity will return to normal upon warming to room temperature.
- Keep tightly closed.
- Dispense in original container or tight, light-resistant container with a child-resistant closure.
- To the Pharmacist:
- When ordering this product, include the product number (or NDC) in the description.
Quoted from the official label, section “How Supplied”.
How to store it
- Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Do not freeze.
- Under recommended storage conditions, a normal darkening of color may occur.
- Such darkening is characteristic of sugar solutions and does not affect therapeutic action.
- Prolonged exposure to temperatures above 30°C (86°F) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable.
- If this condition develops, do not use.
- Prolonged exposure to freezing temperatures may cause change to a semisolid, too viscous to pour.
- Viscosity will return to normal upon warming to room temperature.
- Keep tightly closed.
- Dispense in original container or tight, light-resistant container with a child-resistant closure.
- To the Pharmacist:
- When ordering this product, include the product number (or NDC) in the description.
Quoted from the official label, section “Storage and Handling”.
What is in it
- Lactulose is a synthetic disaccharide in solution form for oral administration.
- Each 15 mL of Lactulose Solution contains:
- 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars).
- Also contains FD&C Yellow No. 6, purified water, and flavoring.
- Sodium hydroxide used to adjust pH.
- The pH range is 2.5 to 6.5.
- Lactulose is a colonic acidifier which promotes laxation.
- The chemical name for lactulose is 4-0-ß-D-galactopyranosyl-D-fructofuranose.
- It has the following structural formula: The molecular weight is 342.30.
- It is freely soluble in water.
- Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (3)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 3 of 3
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | PAI Holdings, LLC dba PAI Pharma |
|---|---|
| Active substance | Lactulose |
| Used in | Digestion, stomach, diabetes and nutrition |
| Strength | 20 g/30mL |
| Form | Solution |
| Route | Oral |
| Packs | 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE · 4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE · 6 CARTON in 1 CASE / 16 CUP, UNIT-DOSE in 1 CARTON / 30 mL in 1 CUP, UNIT-DOSE |
| NDC | 0121-1154 |
| NDC | 0121-1746 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
21 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution17 products
- 10 g/10g
20 g/30mL3
20 g/30mL · 3 companies
- Cardinal Health 107, LLC
- Chartwell Governmental & Specialty RX, LLC.
- PAI Holdings, LLC dba PAI Pharma · this page
- 20 g/20g
- Powder, for Solution4 products
10 g/10g2
10 g/10g · 2 companies
20 g/20g2
20 g/20g · 2 companies
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.