Lactulose 10 g/15mL Solution, 237 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Osmotic Laxative class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Lactulose is a synthetic sugar used to treat constipation. It is broken down in the colon into products that pull water out from the body and into the colon. This water softens stools. Lactulose is also used to reduce the amount of ammonia in the blood of patients with liver disease. It works by drawing ammonia from the blood into the colon where it is removed from the body. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- Lactulose has two main uses. Some products — like Constulose and Kristalose — are prescribed specifically for constipation. Other products, like Enulose and Generlac, are used for...
- For constipation, it usually takes 24 to 48 hours to produce a bowel movement, so don't be worried if nothing happens right away. For portal-systemic encephalopathy, improvement ma...
- How long does it take lactulose to work?
- The most common side effects are digestive — gas, bloating, belching, and mild stomach cramping. These are pretty typical, especially when you first start. The one to watch for is...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lactulose — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.020 | $4.62 / 237 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0271 | $6.42 / 237 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.0465 | $11.02 / 237 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lactulose Solution 10 g/15mL 81033-0241-32 | Kesin | 946 ml | $0.013 | AA | Availability likely | save 36% |
| Enulose 10 g/15mL 45963-0438-64 | Actavis | 473 ml | $0.013 | AA | Availability likely | save 33% |
| Generlac 10 g/15mL 62135-0892-47 | Chartwell | 473 ml | $0.013 | AA | Availability likely | save 33% |
| Lactulose 10 g/15mLthis 00116-4005-08 | Xttrium | 237 ml | $0.019 | AA | Availability likely | — |
| Constulose 10 g/15mL 45963-0439-63 | Actavis | 237 ml | $0.019 | AA | Availability likely | — |
| Lactulose 10 g/15mL 83745-0405-08 | APOZEAL | 237 ml | $0.019 | AA | Availability likely | — |
| Lactulose 10 g/15mL 62135-0003-37 | Chartwell | 237 ml | $0.020 | AA | Availability likely | +2% |
| Lactulose 10 g/15mL 51672-4243-09 | Sun | 1 bottle | $0.022 | AA | Availability likely | +15% |
| Lactulose 10 g/15mL 00121-0873-06 | PAI | 16 cups | — | AA | FDA listed | — |
| Lactulose 20 g/30mL 00121-1154-06 | PAI | 16 cups | — | AA | Discontinued | — |
| Lactulose 20 g/30mL 00121-1746-00 | PAI | 10 cups | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 00121-4577-06 | PAI | 16 cups | — | AA | Discontinued | — |
| Lactulose 10 g/15mL 00527-5125-68 | Lannett | 237 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 17856-0874-03 | Atlantic | 50 cups | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 18124-0002-16 | Fresenius | 473 ml | — | AA | FDA listed | — |
| Lactulose 20 g/30mL 55154-9448-05 | Cardinal | 5 cups | — | AA | FDA listed | — |
| Lactulose Solution 10 g/15mL 61037-0471-02 | Bajaj | 236 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 62135-0002-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 62135-0004-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Enulose 10 g/15mL 63629-8800-01 | Bryant | 473 ml | — | AA | FDA listed | — |
| Lactulose Solution 10 g/15mL 64980-0592-12 | Rising | 118 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 68999-0002-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Lactulose 20 g/30mL 68999-0004-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 82804-0107-47 | Proficient | 473 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 83745-0249-08 | APOZEAL | 237 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 60687-0917-14 | American | 10 cups | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00116-4005-08 You're viewing this | 237 mL in 1 BOTTLE (0116-4005-08) | $0.0195 / mL | $4.61 | 2022-07-01 | Active |
| 00116-4005-10 | 100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) | — | — | 2022-07-01 | Active |
| 00116-4005-11 | 100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) | $0.0493 / mL | $59,196.00 | 2022-07-01 | Active |
| 00116-4005-15 | 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15) | — | — | 2022-07-01 | Active |
| 00116-4005-16 | 473 mL in 1 BOTTLE (0116-4005-16) | $0.0224 / mL | $10.58 | 2022-07-01 | Active |
| 00116-4005-30 | 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) | — | — | 2022-07-01 | Active |
| 00116-4005-32 | 946 mL in 1 BOTTLE (0116-4005-32) | $0.0194 / mL | $18.34 | 2022-07-01 | Active |
This pack accounts for about 10% of this product's recent Medicaid fills; most go to the 473 ml pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 00116-4005-08?
What is the difference between NDC 00116-4005-08 and NDC 00116-4005-15?
What NDC number is used to bill for this package of Lactulose 10 g/15mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
⚠️ Warnings ▾
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 H2 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions Results of preliminary studies in humans and rats suggest that non-absorbable 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.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects 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.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE 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 LD50 The acute oral LD50 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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 reach the colon virtually unchanged. In the colon, lactulose is broken down primarily to lactic acid, and also to small amounts of formic and acetic acids, by the action of colonic bacteria, which results in an increase in osmotic pressure and slight acidification of the colonic contents.
This in turn causes an increase in stool water content and softens the stool. Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24 to 48 hours may be required to produce the desired bowel movement. Lactulose given orally to man and experimental animals resulted in only small amounts reaching the blood.
Urinary excretion has been determined to be 3% or less and is essentially complete within 24 hours.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Lactulose Solution, USP 10 g/15 mL is a colorless to yellow, unflavored solution available in the following container sizes: 15 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-15) 30 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-30) 8 fl. oz. (237 mL) white bottles (NDC 0116-4005-08) 16 fl. oz. (473 mL) white bottles (NDC 0116-4005-16) 32 fl. oz.
(946 mL) white bottles (NDC 0116-4005-32) Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL). Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. 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.
Dispense in original container or in a tight, light-resistant container as defined in the USP, with a child-resistant closure. To The Pharmacist: When ordering this product, include the product number (or NDC) in the description.
📋 Description ▾
DESCRIPTION Lactulose solution is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose 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 water, D&C Yellow No.
10, and FD&C Yellow No. 6. The pH range is 2.5 to 6.5.
Lactulose solution is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-ß-D-galactopyranosyl-D-fructofuranose. It has the following structural formula: C 12 H 22 0 11 The molecular weight is 342.30.
It is freely soluble in water. structure
💬 Information for Patients ▾
Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician.