KRISTALOSE lactulose 10 g/10g Powder, For Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Osmotic Laxative class.
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🏭 Manufacturer & labeler
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🩺 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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🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $9.591 | $287.73 / 30 pouches |
| Medicaid paysCMS SDUD · 12 mo | $0.8888 | $26.66 / 30 pouches |
| Medicare drug plans payPart D · Q2 2026 | $8.45 | $253.43 / 30 pouches |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lactulose 10 g/10g 00121-0965-30 | PAI | 30 pouches | $8.220 | AA | Availability likely | save 14% |
| Lactulose 10 g/10g 73352-0900-15 | Trifluent | 15 pouches | $8.220 | AA | Availability likely | save 14% |
| LACTULOSE Crystalline 10 g/10g 85592-0819-30 | Cumberland | 30 pouches | $8.220 | AA | Availability likely | save 14% |
| Kristalose 10 g/10gthis 66220-0719-30 | Cumberland | 30 pouches | $9.591 | AA | Availability likely | — |
| Lactulose 10 g/10g 69067-0010-15 | Foxland | 15 pouches | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 66220-0719-30 You're viewing this | 30 POUCH in 1 CARTON (66220-719-30) / 10 g in 1 POUCH (66220-719-01) | 2012-01-20 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE KRISTALOSE ® (LACTULOSE) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose 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 adult dosage is 10 g to 20 g of lactulose daily. The dose may be increased to 40 g daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement.
⛔ Contraindications ▾
CONTRAINDICATIONS Since KRISTALOSE ® (LACTULOSE) For Oral Solution contains galactose (less than 0.3 g/10 g as a total sum with lactose), it is contraindicated in patients who require a low galactose diet.
⚠️ Warnings ▾
WARNINGS A theoretical hazard may exist for patients being treated with lactulose 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.
🤒 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.
🔄 Drug Interactions ▾
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. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose.
🤰 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 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY KRISTALOSE ® (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 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 KRISTALOSE ® (LACTULOSE) For Oral Solution is available in single dose packets of 10 g (NDC 66220-719-01) and single dose packets of 20 g (NDC 66220-729-01). The packets are supplied as follows: NDC 66220-719-30 (Carton of thirty 10 g packets) NDC 66220-729-30 (Carton of thirty 20 g packets) STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F). To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured for: CUMBERLAND PHARMACEUTICALS INC. Nashville, TN 37203 KRISTALOSE is a registered trademark of Cumberland Pharmaceuticals Inc. Issued: July 2018
📋 Description ▾
DESCRIPTION KRISTALOSE (lactulose) is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration Each 10 g of lactulose contains less than 0.3 g galactose and lactose as a total sum. The pH range is 3.0 to 7.0. Lactulose is a colonic acidifier which promotes laxation.
The chemical name for lactulose is 4-O-β-D-Galactopyranosyl-D-fructofuranose. It has the following structural formula: The molecular formula is C 12 H 22 O 11 . The molecular weight is 342.30.
It is freely soluble in water. Structural Formula
💬 Information for Patients ▾
Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician.