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SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID 12; 3.5; 10 g/16.1g; g/16.1g; mg/16.1g Powder, Metered, 2 packets

by Camber Pharmaceuticals, Inc. · 2 PACKET in 1 CARTON (31722-874-16) / 16.1 g in 1 PACKET

NDC 31722-0874-16

🏷️ FDA NDC (as labeled) 31722-874-16 billing pads the product segment with a zero

Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA

🗂️ Data synced Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 31722-874-16

Product NDC 31722-874

11-digit billing NDC 31722087416

Application # ANDA212789

SPL Set ID b759dc12-2dc1-4ef4-a375-1a61630d54d6

Established class (EPC) Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Inte

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Inactivated by FDA (certified through Dec 2024)

Route ORAL

Dosage form POWDER, METERED

Substance ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Why two NDCs? The FDA registers this code as 31722-874-16 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 31722-0874-16. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerCamber Pharmaceuticals, Inc.

Application holderHETERO LABS LTD UNIT V

FDA applicationANDA212789 (ANDA)

Labeler code31722

Product typeHuman Prescription Drug

Portfolio603 products on file

🔎 All NDCs from Camber Pharmaceuticals, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid 12; 3.5; 10 g/16.1g; g/16.1g; mg/16.1gthis 31722-0874-16	Camber	2 packets	—	—	Discontinued	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍

2026

Currently FDA-listed

listed with the FDA

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
31722-0874-16 You're viewing this	2 PACKET in 1 CARTON (31722-874-16) / 16.1 g in 1 PACKET	2022-07-18	Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 31722-874-16, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 31722-0874-16, written without dashes as 31722087416. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 31722-0874-16, the first segment (31722) is the labeler code FDA assigned to Camber Pharmaceuticals, Inc.; the middle segment (0874) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.

Who lists this product with the FDA?

Camber Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 94 words ▾

1 INDICATIONS AND USAGE Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is a combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric acid which form magnesium citrate, an osmotic laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients ages 9 years and older.

(1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Preparation and Administration • Each packet of sodium picosulfate, magnesium oxide and anhydrous citric acid must be dissolved with water prior to ingestion and administered according to the dosing regimen. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting and dehydration. ( 2.2 , 5.8 ) • Two doses (one packet per dose) of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution are required for a complete preparation for colonoscopy.

The preferred method is the “Split-Dose” method. The alternative is the “Day Before” method. ( 2.1 ) • Additional fluids must be consumed after every dose of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution in both dosing regimens.

( 2.1 , 5.1 ) • Do not take oral medications within 1 hour of start of each dose. ( 2.1 , 7.2) • If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. ( 2.1 , 7.3 ) • For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information.

( 2.1 , 2.2 , 2.3 ) Split-Dose Dosage Regimen (Preferred Method) ( 2.2 ) • First dose: administer during evening before the colonoscopy • Second dose: administer the next day, during the morning prior to the colonoscopy. Day-Before Dosage Regimen (Alternative Method), if Split-Dosing is inappropriate ( 2.3 ) • First dose: administer during afternoon or early evening before the colonoscopy. • Second dose: administer 6 hours later during evening before colonoscopy.

2.1Important Preparation and Administration Instructions • Correct fluid and electrolyte abnormalities before administration of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution [see Warnings and Precautions ( 5.1 )]. • Two doses (one packet per dose) of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution are required for a complete preparation for colonoscopy either as a Split-Dose (preferred) or Day-Before dosing regimen. • The preferred method is the “Split-Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, the morning of the day of the colonoscopy [see Dosage and Administration ( 2.2 )]. • The alternative method is the “Day Before” method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy [see Dosage and Administration ( 2.3 )]. • Each packet of sodium picosulfate, magnesium oxide and anhydrous citric acid must be dissolved in 5 ounces of cold water prior to ingestion and administered according to the dosing regimen.

Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration and electrolyte disturbances [see Warnings and Precautions ( 5.8 )]. • Additional fluids must be consumed after every dose of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution in both dosing regimens [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )]. • Consume only clear fluids (no solid food) from the start of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution treatment until after the colonoscopy. • Do not eat solid food or dairy and do not drink anything colored red or purple. • Do not drink alcohol. • Do not take other laxatives while taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. • Do not take oral medications within one hour before or after starting sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. • If taking tetracycline o…

💊 Dosage Forms and Strengths 68 words ▾

3 DOSAGE FORMS AND STRENGTHS For oral solution: Each of the two packets contains 10 mg of sodium picosulfate, 3.5 g of magnesium oxide and 12 g of anhydrous citric acid in 16.1g of powder for orange flavor. For oral solution: Each of 2 packets contains 16.1 g of powder for orange flavor: 10 mg sodium picosulfate, 3.5 g magnesium oxide and 12 g anhydrous citric acid (3)

⛔ Contraindications 144 words ▾

4 CONTRAINDICATIONS Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is contraindicated in the following conditions: • Patients with severe renal impairment (creatinine clearance less than 30 mL/minute) which may result in accumulation of magnesium [see Warnings and Precautions ( 5.4 )] • Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6)] • Bowel perforation [see Warnings and Precautions ( 5.6 )] • Toxic colitis or toxic megacolon • Gastric retention • Hypersensitivity to any of the ingredients in sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution [see Adverse Reactions ( 6.2 )] • Severe renal impairment (creatinine clearance less than 30 mL/minute) (4 ) • Gastrointestinal (GI) obstruction or ileus (4 ) • Bowel perforation (4 ) • Toxic colitis or toxic megacolon (4) • Gastric retention (4) • Hypersensitivity to any of the ingredients (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. ( 5.1 , 5.2 , 7.1 ) • Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) • Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold.

( 5.3 , 7.1 ) • Patients with mild to moderate renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. ( 4 , 5.4 , 7.1 ) • Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5 ) • Suspected GI obstruction or perforation: Rule out diagnosis before administration.

( 4 , 5.6 ) • Patients at risk for aspiration: Observe during administration. ( 5.7 ) • Risk of vomiting and other GI complications with ingestion of undissolved powder: Dissolve each packet in 5 ounces of cold water and administered at separate times according to the dosing regimen. ( 2.3 , 2.4 , 5.8 )

5.1Serious Fluid and Electrolyte Abnormalities Advise patients to hydrate adequately before, during, and after the use of sodium picosulfate, magnesium oxide and anhydrous citric acid. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking sodium picosulfate, magnesium oxide and anhydrous citric acid, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly.

Approximately 20% of adult patients in both arms (sodium picosulfate, magnesium oxide and anhydrous citric acid, 2L of PEG + E plus two x 5 mg bisacodyl tablets) of clinical trials of sodium picosulfate, magnesium oxide and anhydrous citric acid had orthostatic changes (changes in blood pressure and/or heart rate) on the day of colonoscopy. In adult clinical trials orthostatic changes were documented up to seven days post colonoscopy. In a single study of patients 9 to 16 years of age, approximately 20% of patients in sodium picosulfate, magnesium oxide and anhydrous citric acid arms had orthostatic changes (changes in blood pressure and/or heart rate) compared with approximately 7% of those who received the comparator (PEG) [see Clinical Studies ( 14 )].

These changes occurred up to five days post colonoscopy. Fluid and electrolyte disturbances can lead to serious adverse reactions including cardiac arrhythmias or seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with sodium picosulfate, magnesium oxide and anhydrous citric acid [see Dosage and Administration ( 2.1 )] .

In addition, use caution when prescribing sodium picosulfate, magnesium oxide and anhydrous citric acid for patients who have conditions or who are using medications that increase the risk for fluid and electrolyte disturbances or that may increase the risk of adverse events of seizure, arrhythmia, and renal impairment [see Drug Interactions ( 7.1 )].

5.2Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing sodium picosulfate, magnesium oxide and anhydrous citric acid for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

5.3Seizures There have been reports of generalized tonic-clonic seizures with the use of bowel preparation products in patients with no p…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: • Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] • Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] • Seizures [see Warnings and Precautions ( 5.3 )] • Use in Patients with Renal Impairment [see Warnings and Precautions ( 5.4 )] • Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see Warnings and Precautions ( 5.5 )] • Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] • Aspiration [see Warnings and Precautions ( 5.7 )] • Risk of Vomiting and Other Gastrointestinal Complications with Ingestion of Undissolved Powder [see Warnings and Precautions ( 5.8 )] Most common adverse reactions are: • Adults (>1%): nausea, headache and vomiting.

( 6.1 ) • Pediatrics 9 to 16 years (>5%): nausea, vomiting, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. In randomized, multicenter, controlled clinical trials, nausea, headache, and vomiting were the most common adverse reactions (>1%) following sodium picosulfate, magnesium oxide and anhydrous citric acid administration. The patients were not blinded to the study drug.

Since abdominal bloating, distension, pain/cramping, and watery diarrhea are known to occur in response to colon cleansing preparations, these effects were documented as adverse events in the clinical trials only if they required medical intervention (such as a change in study drug or led to study discontinuation, therapeutic or diagnostic procedures, met the criteria for a serious adverse event), or showed clinically significant worsening during the study that was not in the frame of the usual clinical course, as determined by the investigator.

Sodium picosulfate, magnesium oxide and anhydrous citric acid was compared for colon cleansing effectiveness with a preparation containing two liters (2L) of polyethylene glycol plus electrolytes solution (PEG + E) and two 5 mg bisacodyl tablets, all administered the day before the procedure. Table 1 displays the most common adverse reactions in Study 1 and Study 2 for the sodium picosulfate, magnesium oxide and anhydrous citric acid Split-Dose and Day-Before dosing regimens, respectively, each as compared to the comparator preparation.

Table 1: Treatment-Emergent Adverse Reactions observed in at Least (>1%) of Patients using the Split-Dose Regimen and Day-Before Regimen ** Adverse Reaction S tudy 1: Split-Dose Regimen S tudy 2: Day-Before Regimen S od i u m picosulfate, magnesium oxide and anhydrous citric acid (N=305) n (% = n/N) 2 L PEG+E* w i th 2 x 5-mg bisacodyl tablets (N=298) n (% = n/N) S od i u m picosulfate, magnesium oxide and anhydrous citric acid (N=296) n (% = n/N) 2 L PEG+E* w i th 2 x 5mg bisacodyl tablets (N=302) n (% = n/N) Nausea 8 (2.6) 11 (3.7) 9 (3.0) 13 (4.3) Headache 5 (1.6) 5 (1.7) 8 (2.7) 5 (1.7) Vomiting 3 (1.0) 10 (3.4) 4 (1.4) 6 (2.0) * 2L PEG + E = two liters polyethylene glycol plus electrolytes solution. ** abdominal bloating, distension, pain/cramping, and watery diarrhea not requiring an intervention were not collected Electrolyte Abnormalities In general, sodium picosulfate, magnesium oxide and anhydrous citric acid was associated with numerically higher rates of abnormal electrolyte shifts on the day of colonoscopy compared to the preparation containing 2L of PEG + E plus two x 5-mg bisacodyl tablets (Table 2).

These shifts were transient in nature and numerically similar between treatment…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Drugs that increase risks due to fluid and electrolyte changes. (7.1)

7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing sodium picosulfate, magnesium oxide and anhydrous citric acid for patients with conditions and/or who are taking other drugs that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )].

7.2Potential for Reduced Drug Absorption Sodium picosulfate, magnesium oxide and anhydrous citric acid can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1 )]: • Administer oral medications at least one hour before of the start of administration of sodium picosulfate, magnesium oxide and anhydrous citric acid. • Administer tetracycline and fluoroquinolone antibiotics [see Drug Interactions ( 7.3 )], iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of sodium picosulfate, magnesium oxide and anhydrous citric acid.

7.3Antibiotics Prior or concomitant use of antibiotics with sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution may reduce efficacy of sodium picosulfate, magnesium oxide and anhydrous citric acid as conversion of sodium picosulfate to its active metabolite BHPM is mediated by colonic bacteria.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no data with sodium picosulfate, magnesium oxide and anhydrous citric acid use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In an animal reproduction study, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based on body surface area during organogenesis.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data A reproduction study with sodium picosulfate, magnesium oxide and anhydrous citric acid has been performed in pregnant rats following oral administration of up to 2,000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area) during the period of organogenesis. There was no evidence of harm to the fetus due to sodium picosulfate, magnesium oxide and anhydrous citric acid. A reproduction study in rabbits was not adequate, as treatment-related mortalities were observed at all doses.

A pre and postnatal development study with sodium picosulfate, magnesium oxide and anhydrous citric acid in rats showed no evidence of any adverse effect on pre and postnatal development at oral doses up to 2,000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area). Published reproduction studies with sodium picosulfate in pregnant rats and rabbits during the period of organogenesis did not show evidence of harm to the fetus at doses up to 100 mg/kg (approximately 49 and 98 times, respectively, the recommended human dose of 10 mg sodium picosulfate based on body surface area).

8.2Lactation Risk Summary There are no data on the presence of magnesium oxide or anhydrous citric acid in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Published data on lactating women indicate that the active metabolite of sodium picosulfate, bis-( p -hydroxyphenyl)-pyridyl-2-methane (BHPM) remained below the limit of detection (1 ng/mL) in breast milk after both single and multiple doses of 10 mg/day. There are no data on the effects of sodium picosulfate on the breastfed infant or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sodium picosulfate, magnesium oxide and anhydrous citric acid and any potential adverse effects on the breastfed infant from sodium picosulfate, magnesium oxide and anhydrous citric acid or the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of sodium picosulfate, magnesium oxide and anhydrous citric acid have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years of age and older. Use of sodium picosulfate, magnesium oxide and anhydrous citric acid in this age group is supported by evidence from adequate and well-controlled trials of sodium picosulfate, magnesium oxide and anhydrous citric acid in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age [see Clinical Studies ( 14 )].

The safety profile of sodium picosulfate, magnesium oxide and anhydrous citric acid in this pediatric population was similar to that seen in adults [see Adverse Reactions ( 6.1 )]. Monitor for possible hypoglycemia in pediatric patients, as sodium picosulfate, magnesium oxide and anhydrous citric acid has no caloric substrate. The safety and effectiveness of sodium picosulfate, magnesium oxide and an…

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use 172 words ▾

🧓 Geriatric Use 80 words ▾

8.5Geriatric Use Of the 1,201 patients in clinical trials who received sodium picosulfate, magnesium oxide and anhydrous citric acid, 215 (18%) patients were 65 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. However, elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 )].

🆘 Overdosage 53 words ▾

10 OVERDOSAGE Overdosage of more than the recommended dose of sodium picosulfate, magnesium oxide and anhydrous citric acid may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances [see Warnings and Precautions ( 5.1 )]. Monitor for fluid and electrolyte disturbances and treat symptomatically.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sodium picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.

12.2Pharmacodynamics The stimulant laxative activity of sodium picosulfate together with the osmotic laxative activity of magnesium citrate produces a purgative effect which, when ingested with additional fluids, produces watery diarrhea.

12.3Pharmacokinetics Absorption After administration of the first packet of sodium picosulfate, magnesium oxide and anhydrous citric acid in 16 healthy subjects, mean maximum concentration (C max ) for picosulfate of 2.3 ± 1.4 ng/mL was reached at 2 hours. After administration of 2 packets of sodium picosulfate, magnesium oxide and anhydrous citric acid separated by 6 hours, picosulfate reached the mean C max of 3.2 ± 2.6 ng/mL at approximately 7 hours (T max ). In the same study, baseline uncorrected magnesium reached a C max of approximately 1.9 mEq/L, which occurred at 10 hours post first packet administration (T max ).

This represents an approximately 20% increase from the baseline. Distribution The apparent volume of distribution (V/F) for picosulfate was 4,199 liters in healthy adults. Metabolism and Elimination Sodium picosulfate, which is a prodrug, is converted to its active metabolite, BHPM, by colonic bacteria.

Plasma concentration of the free BHPM were low, and below the lower limit of quantification (0.1 ng/mL) in 13 out of 16 subjects studied. The fraction of the sodium picosulfate dose excreted unchanged in urine was 0.2%. In urine, the majority of excreted BHPM was in the glucuronide- conjugated form.

The terminal half-life of sodium picosulfate was 7.4 hours. The apparent clearance (CL/F) of picosulfate was 629 L/h. Use in Specific Populations Pediatric Patients Pharmacokinetics of picosulfate was studied in pediatric patients aged from 9 to 16 years old.

For picosulfate, the apparent clearance is from 316 to 409 L/h. The corresponding estimates for apparent volume of distribution are from 2457 to 3935 liters. The derived half-life using these model estimates would be 7 hours.

The picosulfate reached the mean C max of 3.5 ± 2.1 ng/mL at approximately 6 to 7 hours (T max ) The baseline uncorrected mean serum magnesium concentration was 2.02 mEq/L at 10 hours after the first dose of sodium picosulfate, magnesium oxide and anhydrous citric acid and ranged from 1.7 to 2.46 mEq/L in pediatric patients from 9 to 16 years of age. Drug Interaction Studies In an in vitro study using human liver microsomes, sodium picosulfate did not inhibit the major CYP enzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5) evaluated.

Based on an in vitro study using freshly isolated hepatocyte culture, sodium picosulfate is not an inducer of CYP1A2, CYP2B6 or CYP3A4/5.

🧬 Mechanism of Action 56 words ▾

📦 How Supplied / Storage and Handling 109 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid for Oral Solution is supplied in a carton containing 2 packets, each holding 16.1 grams of powder in orange flavor, along with a pre-marked dosing cup. Each packet for orange flavor contains 10 mg of sodium picosulfate, 3.5 g of magnesium oxide and 12 g anhydrous citric acid. The excipients for orange flavor contains glyceryl behenate, orange flavor, potassium bicarbonate and saccharin sodium.

The orange flavor contains dl-alpha-Tocopherol and maize maltodextrin. Orange flavor: Kit, 2 packets and cup NDC 31722-874-16 Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

📋 Description 212 words ▾

11 DESCRIPTION Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is available in orange flavor, and is provided in two packets. The contents of each is to be dissolved in 5 ounces of cold water and consumed. Each packet for orange flavor contains 10 mg sodium picosulfate, USP, 3.5 g magnesium oxide, USP and 12 g anhydrous citric acid, USP.

The product also contains the following inactive ingredients: glyceryl behenate, orange flavor (contains dl-alpha-Tocopherol and Maize maltodextrin), potassium bicarbonate and saccharin sodium. The following is a description of the three active ingredients: Sodium picosulfate is a stimulant laxative. Sodium Picosulfate • Chemical name: 4,4’-(2-Pyridylmethylene) diphenyl bis (hydrogen sulfate) disodium salt, monohydrate • Chemical formula: C 18 H 13 NNa 2 O 8 S 2 .H 2 O • Molecular weight: 499.4 • Structural formula: • Sodium Picosulfate Magnesium citrate, which is formed in solution by the combination of magnesium oxide and anhydrous citric acid, is an osmotic laxative.

Magnesium Oxide • Chemical name: Magnesium oxide • Chemical formula: Mg O • Molecular weight: 40.3 • Structural formula: Mg O Anhydrous Citric Acid • Chemical name: 1,2,3-propanetricarboxylic acid, 2-hydroxy- • Chemical formula: C 6 H 8 O 7 • Molecular weight: 192.13 • Structural formula: Anhydrous citric acid sodpicomgoandanhydrouscitricacidstructure1 sodpicomgoandanhydrouscitricacidstructure2

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instruct patients: • Each packet must be dissolved in 5 ounces of cold water and administered according to the dosing regimen. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances [see Warnings and Precautions ( 5.8 )]. • Two doses (one packet per dose) of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution are required for a complete preparation for colonoscopy either as a Split-Dose (preferred) or Day-Before dosing regimen. • Not to take other laxatives while they are taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. • Do not eat solid food or dairy and do not drink anything colored red or purple. • Do not drink alcohol. • Do not take oral medications within one hour of starting sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. • If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. • To follow the directions in the Instructions for Use, for either the Split-Dose or the Day-Before regimen, as prescribed. • To consume additional fluids after each dose of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. • To delay the second dose of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution, if severe bloating, distention, or abdominal pain occurs following the first dose until the symptoms resolve. • To contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution or if they experience altered consciousness (e.g. confusion, delirium, loss of consciousness) or seizures [see Warnings and Precautions ( 5.1 , 5.3 , 5.4 )].

Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd.

Sangareddy - 502313, Telangana, India. Revised: 08/2022 sodpicomgoandanhydrouscitricacidcamberlogo1

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

cardiomyopathy: A disease of the heart muscle that makes it harder for the heart to pump blood.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prodrug: A medicine that is inactive when taken and must be changed by the body into its working form.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serious adverse event: A harmful event during treatment that is life-threatening, requires hospital care, or causes lasting harm.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 31722-0873-90 · Camber 31722-0875-90 · Camber →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID 12; 3.5; 10 g/16.1g; g/16.1g; mg/16.1g Powder, Metered, 2 packets

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