Sucralfate 1 g/10mL Suspension, 420 mL — NDC 65162-062-05 (Billing 65162-0062-05)
This is a package of 420 mL of Sucralfate 1 g/10mL Suspension from Amneal Pharmaceuticals LLC, marketed since Dec 2019 and currently FDA-listed; retail pharmacies pay about $0.1241 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 65162-062-05 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 65162 labeler · 062 product · 05 package
- Package marketed since
- Dec 2, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 420 mL per package
- Barcode (UPC-A, from the NDC)
- 3 6516206205 2
- Medicaid fills, this package
- 38,556 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 016133
- GCN: 07651
- GPI-14 (Medi-Span): 49300010001820
- HICL (First Databank): 001186
- AHFS class code: 56:28.32.00
- RxCUI (RxNorm): 313123
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Aluminum Complex class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats an active duodenal ulcer, which is a sore in the first part of your small intestine. Treatment usually lasts up to 8 weeks. The tablets can also be used at a lower dose t...
- Take it by mouth on an empty stomach, as your prescriber directs. For an active ulcer, the label describes four doses a day. Keep going for the full course even if you feel better,...
- Yes, for pain relief if your doctor allows. Just keep them at least 30 minutes before or after your sucralfate dose.
- Constipation is the most common one, though most people have no trouble. Some get nausea, diarrhea, dry mouth, dizziness or a rash. Call your doctor if something bothers you or doe...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.124 | $52.12 / 420 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1503 | $63.13 / 420 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.2427 | $101.93 / 420 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 65162-0062-05 You're viewing this Main listing | 420 mL in 1 BOTTLE | $0.1241 / mL | $52.13 | 2019-12-02 | — | Active |
| 65162-0062-48 65162-062-48 | 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE | — | — | 2019-12-02 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Sucralfate 1 g/10mL Suspension?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sucralfate 1 g/10mL 50742-0386-42 | Ingenus | 420 ml | $0.115 | AB | Discontinued | save 7% |
| Sucralfate 1 g/10mL 66689-0305-16 | VistaPharm, | 1 bottle | $0.116 | AB | Availability likely | save 6% |
| sucralfate 1 g/10mL 00378-9205-35 | Mylan | 420 ml | $0.124 | AB | Discontinued | — |
| Sucralfate 1 g/10mL 00713-0791-75 | Cosette | 420 ml | $0.124 | AB | Availability likely | — |
| Sucralfate 1 g/10mL 13668-0754-42 | Torrent | 420 ml | $0.124 | AB | Availability likely | — |
| sucralfate 1 g/10mL 64380-0149-01 | Strides | 420 ml | $0.124 | AB | Availability likely | — |
| Sucralfate 1 g/10mLthis 65162-0062-05 | Amneal | 420 ml | $0.124 | AB | Availability likely | — |
| Sucralfate 1 g/10mL 82182-0106-14 | Pacific | 420 ml | $0.124 | — | Availability likely | — |
| Sucralfate 1 g/10mL 52817-0840-16 | TruPharma, | 473 ml | $0.137 | AB | Availability likely | +10% |
| Carafate 1 g/10mL 58914-0170-14 | Allergan, | 414 ml | $0.609 | — | FDA listed | +391% |
| Sucralfate 1 g/10mL 00121-0974-00 | PAI | 10 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 00904-7470-01 | Major | 30 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 17856-0306-01 | ATLANTIC | 72 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 42291-0781-42 | AvKARE | 420 ml | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 50268-0745-14 | AvPAK | 40 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 54738-0005-42 | Richmond | 420 ml | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 55154-4348-05 | Cardinal | 5 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 55154-5790-05 | Cardinal | 5 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 60687-0738-08 | American | 10 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 68094-0041-61 | Precision | 10 cups | — | AB | FDA listed | — |
| Sucralfate oral suspension 1 g/10mL 68462-0827-61 | Glenmark | 420 ml | — | AB | FDA listed | — |
| sucralfate 1 g/10mL 72162-2479-02 | Bryant | 420 ml | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 81033-0149-44 | Kesin | 40 cups | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Sucralfate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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100 mg / 10 mL
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
88 mg / 10 mL
UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
-
0.05 mg / 10 mL
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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990 mg / 10 mL
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
25 mg / 10 mL
UNII MRJ667KA5E
Methylcellulose is a plant-derived thickening agent made by chemically modifying cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to create the right consistency, and sometimes a disintegrant to help the tablet break apart when swallowed.
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20 mg / 10 mL
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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20 mg / 10 mL
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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2000 mg / 10 mL
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
7011.95 mg / 10 mL
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.
9 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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Amneal Pharmaceuticals LLC labeler code 65162
- Citalopram 10 mg Tablet NDC 65162-052-03
- Citalopram 20 mg Tablet NDC 65162-053-03
- Citalopram 40 mg Tablet NDC 65162-054-03
- Raloxifene Hydrochloride 60 mg Tablet, Film Coated NDC 65162-057-03
- Sevelamer Carbonate 800 mg Tablet, Film Coated NDC 65162-058-03
- Ritonavir 100 mg Tablet NDC 65162-061-06
- Sodium Oxybate 500 mg/mL Solution NDC 65162-065-87
- Lurasidone Hydrochloride 60 mg Tablet, Coated NDC 65162-082-03
- Itraconazole 10 mg/mL Solution NDC 65162-087-34
- Milnacipran HCl 12.5 mg Tablet NDC 65162-091-06
- Milnacipran HCl 25 mg Tablet NDC 65162-092-06
- Milnacipran HCl 50 mg Tablet NDC 65162-093-06
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Active Duodenal Ulcer: The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate Oral Suspension should be administered on an empty stomach. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Sucralfate Oral Suspension.
While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see PRECAUTIONS Geriatric Use ). Call your doctor for medical advice about side effects.
You may report side effects to Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
⛔ Contraindications ▾
CONTRAINDICATIONS Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
⚠️ Warnings ▾
WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Sucralfate Oral Suspension. Administer Sucralfate Oral Suspension only by the oral route. Do not administer intravenously.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%).
Other adverse effects reported in less than 0.5% of the patients are listed below by body system: Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting Dermatological: pruritus, rash Nervous System: dizziness, insomnia, sleepiness, vertigo Other: back pain, headache Post-marketing cases of hypersensitivity have been reported with the use of Sucralfate Oral Suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.
Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate. Cases of hyperglycemia have been reported with sucralfate. Bezoars have been reported in patients treated with sucralfate.
The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.
🔄 Drug Interactions ▾
Drug Interactions Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.
The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Due to Sucralfate Oral Suspension's potential to alter the absorption of some drugs, Sucralfate Oral Suspension should be administered separately from other drugs when alterations in bioavailability are felt to be critical.
In these cases, patients should be monitored appropriately.
🤰 Pregnancy ▾
Pregnancy Teratogenic effects Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. 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.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of Sucralfate Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see DOSAGE AND ADMINISTRATION ).
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see PRECAUTIONS Special Populations: Chronic Renal Failure and Dialysis Patients ). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
OVERDOSAGE Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract.
Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine. Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action.
The following observations also appear pertinent: Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site. In vitro , a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions. In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.
In vitro , sucralfate adsorbs bile salts. These observations suggest that sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of sucralfate.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Sucralfate Oral Suspension 1 g/10 mL is supplied as a pink colored, cherry flavored suspension available as follows: Bottle of 420 mL NDC 65162-062-05 10 mL unit dose cup NDC 65162-062-47 10 unit dose cups in a tray NDC 65162-062-48 SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2023-03
📋 Description ▾
DESCRIPTION Sucralfate Oral Suspension contains sucralfate, USP and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate, USP per 10 mL. Sucralfate Oral Suspension also contains: cherry flavor, colloidal silicon dioxide, FD&C Red #40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion, and sorbitol solution.
Therapeutic category: antiulcer. Chemical Structure
⚠️ Precautions ▾
PRECAUTIONS The physician should read the " PRECAUTIONS " section when considering the use of sucralfate oral suspension in pregnant or pediatric patients, or patients of childbearing potential. Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the post healing frequency or severity of duodenal ulceration.
Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with Sucralfate Oral Suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of Sucralfate Oral Suspension might be necessary.
Special Populations: Chronic Renal Failure and Dialysis Patients When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of sucralfate and aluminum-containing products adequately excrete aluminum in the urine.
Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment.
Sucralfate should be used with caution in patients with chronic renal failure. Drug Interactions Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports.
However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy. The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction.
Due to Sucralfate Oral Suspension's potential to alter the absorption of some drugs, Sucralfate Oral Suspension should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose).
There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.
Pregnancy Teratogenic effects Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. 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.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers 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 sucralfate is administered to a nursing woman.
🔬 Clinical Studies ▾
CLINICAL TRIALS In a multicenter, double-blind, placebo-controlled study of Sucralfate Oral Suspension, a dosage regimen of 1 gram (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing. Results from Clinical Trials Healing Rates for Acute Duodenal Ulcer Treatment n Week 2 Healing Rates Week 4 Healing Rates Week 8 Healing Rates Sucralfate Oral Suspension 145 23 (16%) * 66 (46%) † 95 (66%) ‡ Placebo 147 10 (7%) 39 (27%) 58 (39%) * P =0.016 † P =0.001 ‡ P =0.0001 Equivalence of Sucralfate Oral Suspension to sucralfate tablets has not been demonstrated.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose). There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL 2 Bottle Label