KRISTALOSE — Powder, for Solution

Overview

Brand name

KRISTALOSE

Generic name

lactulose

Dosage form

Powder, for Solution

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Cumberland Pharmaceuticals Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

2

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Lactulose	10 g/10g	391937	View
Lactulose	20 g/20g	391937	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Powder, for Solution

Route of administration

Oral

Presentations

4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Acidifying Activity [MoA]	MoA	All 14 members
Osmotic Activity [MoA]	MoA	All 105 members
Osmotic Laxative [EPC]	EPC	All 103 members
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]	PE	All 53 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

074712

Application type

ANDA · Abbreviated New Drug Application

Approval date

December 10, 1997

Sponsor

APOTEX

Products on application

2

Submissions recorded

3

Products approved under application 074712.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
074712-001	LACTULOSE	FOR SOLUTION		LACTULOSE	Prescription	AA	RS
074712-002	LACTULOSE	FOR SOLUTION		LACTULOSE	Prescription	AA	RS

Therapeutic equivalence

Source: Orange Book

TE code

AA

Reference Listed Drug

No

Reference Standard

Yes

What this rating means: Therapeutically equivalent — no known or suspected bioequivalence problems (conventional dosage forms)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 074712.
Type	No.	Action	Status	Date	Review
Supplement	11	Labeling	Approved	April 14, 2026	Standard
Supplement	1	Manufacturing (CMC)	Approved	March 14, 2001	—
Original application	1		Approved	December 10, 1997	—

Review documents

0 · Original application · December 14, 2011

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20180917). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20180917

Indications and Usage

openFDA Drug Labeling

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

openFDA Drug Labeling

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

openFDA Drug Labeling

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

openFDA Drug Labeling

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

openFDA Drug Labeling

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

openFDA Drug Labeling

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.

Description

openFDA Drug Labeling

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

Overdosage

openFDA Drug Labeling

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.

How Supplied / Storage and Handling

openFDA Drug Labeling

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

Adverse event reports

Source: openFDA FAERS

38,217

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LACTULOSE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
66220-719-30	66220-719	Cumberland Pharmaceuticals Inc.	30 POUCH in 1 CARTON (66220-719-30) / 10 g in 1 POUCH (66220-719-01)	January 20, 2012
66220-729-30	66220-729	Cumberland Pharmaceuticals Inc.	30 POUCH in 1 CARTON (66220-729-30) / 20 g in 1 POUCH (66220-729-01)	January 20, 2012
66220-719	66220-719	Cumberland Pharmaceuticals Inc.	—	January 20, 2012
66220-729	66220-729	Cumberland Pharmaceuticals Inc.	—	January 20, 2012

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.