CIMETIDINE HYDROCHLORIDE 300 mg/5mL Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-2 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Cimetidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. Over-the-counter cimetidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach. Cimetidine is in a class of medications called H2 blockers. It decreases the amount of acid made in the stomach.
Read the full MedlinePlus article ↗- The over-the-counter tablets — brands like Acid Reducer, Equate Cimetidine, and Basic Care Acid Reducer — are intended for everyday heartburn relief and prevention. You take one ta...
- What's the difference between the OTC cimetidine tablets and the prescription version?
- It's actually best not to take them at the exact same time. Antacids can interfere with how well cimetidine is absorbed from your stomach, which means the cimetidine may not work a...
- Can I take antacids at the same time as cimetidine?
Patient education
Supplement & herbal interactions
Cimetidine may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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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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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII L7T10EIP3A
A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
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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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UNII LQA7B6G8JG
A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 70WT22SF4B
A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
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UNII 8KW3E207O2
A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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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 mL | 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 · Q2 2026 | $0.6658 | $66.58 / 100 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cimetidine Hydrochloride 300 mg/5mL 00121-1025-08 | PAI | 237 ml | $0.599 | AA | Availability likely | — |
| Cimetidine Hydrochloride 300 mg/5mLthis 62135-0809-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Cimetidine Hydrochloride 300 mg/5mL 68999-0809-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 62135-0809-24 You're viewing this | 2 TRAY in 1 BOX (62135-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-809-05) | — | — | 2024-10-22 | Active |
| 62135-0809-37 | 237 mL in 1 BOTTLE (62135-809-37) | $0.6002 / mL | $142.25 | 2024-05-06 | Active |
This pack shows little to no recent Medicaid volume — the 237 ml pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 62135-0809-24?
What NDC number is used to bill for this package of CIMETIDINE HYDROCHLORIDE 300 mg/5mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
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 | ✓ Available |
| Inactive ingredients (structured) | ✓ 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 | ✓ Available |
| 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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cimetidine Hydrochloride Oral Solution is indicated in: (1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see Dosage and Administration-Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain.
However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. (2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to 5 years.
(3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. (4) Erosive gastroesophageal reflux disease (GERD).
Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established (see Dosage and Administration-GERD ).
(5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Duodenal Ulcer Active Duodenal Ulcer: Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing (see Clinical Pharmacology-Antisecretory Activity-Acid Secretion ). This is supported by recent clinical trials (see Clinical Pharmacology-Clinical Trials Duodenal Ulcer-Active Duodenal Ulcer ). Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime dosage regimen (h.s.).
In a U.S. oral dose-ranging study of 400 mg h.s., 800 mg h.s. and 1600 mg h.s., a continuous dose response relationship for ulcer healing was demonstrated. However, 800 mg h.s. is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg h.s. and 1600 mg h.s. being small), maximal pain relief, a decreased potential for drug interactions (see Precautions-Drug Interactions ) and maximal patient convenience. Patients unhealed at 4 weeks, or those with persistent symptoms, have been shown to benefit from two to four weeks of continued therapy.
It has been shown that patients who both have an endoscopically demonstrated ulcer larger than 1 cm and are also heavy smokers (i.e., smoke one pack of cigarettes or more per day) are more difficult to heal. There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with cimetidine 1,600 mg at bedtime. While early pain relief with either 800 mg h.s. or 1,600 mg h.s. is equivalent in all patients, 1,600 mg h.s. provides an appropriate alternative when it is important to ensure healing within four weeks for this subpopulation.
Alternatively, approximately 94% of all patients will also heal in eight weeks with cimetidine 800 mg h.s. Other cimetidine regimens in the U.S. which have been shown to be effective are: 300 mg four times daily, with meals and at bedtime, the original regimen with which U.S. physicians have the most experience, and 400 mg twice daily, in the morning and at bedtime (see Clinical Pharmacology Clinical Trials-Duodenal Ulcer-Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain.
However, simultaneous administration of cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. While healing with cimetidine often occurs during the first week or two, treatment should be continued for 4 to 6 weeks unless healing has been demonstrated by endoscopic examination. Maintenance Therapy for Duodenal Ulcer: In those patients requiring maintenance therapy, the recommended adult oral dose is 400 mg at bedtime.
Active Benign Gastric Ulcer The recommended adult oral dosage for short-term treatment of active benign gastric ulcer is 800 mg h.s., or 300 mg four times a day with meals and at bedtime. Controlled clinical studies were limited to six weeks of treatment (see Clinical Pharmacology-Clinical Trials ). 800 mg h.s. is the preferred regimen for most patients based upon convenience and reduced potential for drug interactions.
Symptomatic response to cimetidine does not preclude the presence of a gastric malignancy. It is important to follow gastric ulcer patients to assure rapid progress to complete healing. Erosive Gastroesophageal Reflux Disease (GERD) The recommended adult oral dosage for the treatment of erosive esophagitis that has been diagnosed by endoscopy is 1,600 mg daily in divided doses (800 mg b.i.d. or 400 mg q.i.d.) for 12 weeks.
The use of cimetidine beyond 12 weeks has not been established. Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome) Recommended adult oral dosage: 300 mg four times a day with meals and at bedtime. In some patients it may be necessary to administer higher doses more frequently.
Doses should be adjusted to individual patient needs, but should not usually exceed 2400 mg per day and should continue as long as clini…
⛔ Contraindications ▾
CONTRAINDICATIONS Cimetidine is contraindicated for patients known to have hypersensitivity to the product.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Adverse effects reported in patients taking cimetidine are described below by body system. Incidence figures of 1 in 100 and greater are generally derived from controlled clinical studies.
Gastrointestinal Diarrhea (usually mild) has been reported in approximately 1 in 100 patients. CNS Headaches ranging from mild to severe have been reported in 3.5% of 924 patients taking 1600 mg/day, 2.1% of 2,225 patients taking 800 mg/day and 2.3% of 1,897 patients taking placebo. Dizziness and somnolence (usually mild) have been reported in approximately 1 in 100 patients on either 1600 mg/day or 800 mg/day.
Reversible confusional states, e.g., mental confusion, agitation, psychosis, depression, anxiety, hallucinations, disorientation, have been reported predominantly, but not exclusively, in severely ill patients. They have usually developed within 2 to 3 days of initiation of cimetidine therapy and have cleared within 3 to 4 days of discontinuation of the drug. Endocrine Gynecomastia has been reported in patients treated for one month or longer.
In patients being treated for pathological hypersecretory states, this occurred in about 4% of cases while in all others the incidence was 0.3% to 1% in various studies. No evidence of induced endocrine dysfunction was found, and the condition remained unchanged or returned toward normal with continuing cimetidine treatment. Reversible impotence has been reported in patients with pathological hypersecretory disorders, e.g., Zollinger-Ellison Syndrome, receiving cimetidine, particularly in high doses, for at least 12 months (range 12 to 79 months, mean 38 months).
However, in large-scale surveillance studies at regular dosage, the incidence has not exceeded that commonly reported in the general population. Hematologic Decreased white blood cell counts in cimetidine-treated patients (approximately 1 per 100,000 patients), including agranulocytosis (approximately 3 per million patients), have been reported, including a few reports of recurrence on rechallenge. Most of these reports were in patients who had serious concomitant illnesses and received drugs and/or treatment known to produce neutropenia.
Thrombocytopenia (approximately 3 per million patients) and, very rarely, cases of pancytopenia or aplastic anemia have also been reported. As with some other H 2 -receptor antagonists, there have been extremely rare reports of immune hemolytic anemia. Hepatobiliary Dose-related increases in serum transaminase have been reported.
In most cases they did not progress with continued therapy and returned to normal at the end of the therapy. There have been rare reports of cholestatic or mixed cholestatic-hepatocellular effects. These were usually reversible.
Because of the predominance of cholestatic features, severe parenchymal injury is considered highly unlikely. However, as in occasional liver injury with other H 2 -receptor antagonists, in exceedingly rare circumstances fatal outcomes have been reported. There has been reported a single case of biopsy-proven periportal hepatic fibrosis in a patient receiving cimetidine.
Rare cases of pancreatitis, which cleared on withdrawal of the drug, have been reported. Hypersensitivity Rare cases of fever and allergic reactions including anaphylaxis and hypersensitivity vasculitis, which cleared on withdrawal of the drug, have been reported. Renal Small, possibly dose-related increases in plasma creatinine, presumably due to competition for renal tubular secretion, are not uncommon and do not signify deteriorating renal function.
Rare cases of interstitial nephritis and urinary retention, which cleared on withdrawal of the drug, have been reported. Cardiovascular Rare cases of bradycardia, tachycardia and A-V heart block have been reported with H 2 -receptor antagonists. Musculoskeletal There have been rare repor…
🆘 Overdosage ▾
OVERDOSAGE Studies in animals indicate that toxic doses are associated with respiratory failure and tachycardia that may be controlled by assisted respiration and the administration of a beta-blocker. Reported acute ingestions orally of up to 20 grams have been associated with transient adverse effects similar to those encountered in normal clinical experience. The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
There have been reports of severe CNS symptoms, including unresponsiveness, following ingestion of between 20 and 40 grams of cimetidine, and extremely rare reports following concomitant use of multiple CNS-active medications and ingestion of cimetidine at doses less than 20 grams. An elderly, terminally ill dehydrated patient with organic brain syndrome receiving concomitant antipsychotic agents and cimetidine 4800 mg intravenously over a 24-hour period experienced mental deterioration with reversal on Cimetidine discontinuation.
There have been two deaths in adults who have been reported to ingest over 40 grams orally on a single occasion.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Cimetidine competitively inhibits the action of histamine at the histamine H 2 receptors of the parietal cells and thus is a histamine H 2 receptor antagonist. Cimetidine is not an anticholinergic agent. Studies have shown that cimetidine inhibits both daytime and nocturnal basal gastric acid secretion.
Cimetidine also inhibits gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine and insulin. Antisecretory Activity Acid Secretion: Nocturnal: Cimetidine 800 mg orally at bedtime reduces mean hourly H+ activity by greater than 85% over an eight-hour period in duodenal ulcer patients, with no effect on daytime acid secretion. Cimetidine 1600 mg orally h.s. produces 100% inhibition of mean hourly H+ activity over an eight-hour period in duodenal ulcer patients, but also reduces H+ activity by 35% for an additional five hours into the following morning.
Cimetidine 400 mg b.i.d. and 300 mg q.i.d. decrease nocturnal acid secretion in a dose-related manner, i.e., 47% to 83% over a six-to eight-hour period and 54% over a nine-hour period, respectively. Food Stimulated: During the first hour after a standard experimental meal, oral cimetidine 300 mg inhibited gastric acid secretion in duodenal ulcer patients by at least 50%. During the subsequent two hours cimetidine inhibited gastric acid secretion by at least 75%.
The effect of a 300 mg breakfast dose of cimetidine continued for at least four hours and there was partial suppression of the rise in gastric acid secretion following the luncheon meal in duodenal ulcer patients. This suppression of gastric acid output was enhanced and could be maintained by another 300 mg dose of cimetidine given with lunch. In another study, cimetidine 300 mg was given with the meal increased gastric pH as compared with placebo.
Mean Gastric pH Cimetidine Placebo 1 hour 3.5 2.6 2 hours 3.1 1.6 3 hours 3.8 1.9 4 hours 6.1 2.2 24-Hour Mean H+ Activity: Cimetidine 800 mg h.s., 400 mg b.i.d. and 300 mg q.i.d. all provide a similar, moderate (less than 60%) level of 24-hour acid suppression. However, the 800 mg h.s. regimen exerts its entire effect on nocturnal acid, and does not affect daytime gastric physiology. Chemically Stimulated: Oral cimetidine significantly inhibited gastric acid secretion stimulated by betazole (an isomer of histamine), pentagastrin, caffeine and insulin as follows: Stimulant Stimulant Dose Cimetidine % Inhibition Betazole 1.5 mg/kg (sc) 300 mg (po) 85% at 21/2 hours Pentagastrin 6 mcg/kg/hr (iv) 100 mg/hr (iv) 60% at 1 hour Caffeine 5 mg/kg/hr (iv) 300 mg (po) 100% at 1 hour Insulin 0.03 units/kg/hr (iv) 100 mg/hr (iv) 82% at 1 hour When food and betazole were used to stimulate secretion, inhibition of hydrogen ion concentration usually ranged from 45 to 75% and the inhibition of volume ranged from 30 to 65%.
Pepsin: Oral cimetidine 300 mg reduced total pepsin output as a result of the decrease in volume of gastric juice. Intrinsic Factor: Intrinsic factor secretion was studied with betazole as a stimulant. Oral cimetidine 300 mg inhibited the rise in intrinsic factor concentration produced by betazole, but some intrinsic factor was secreted at all times.
Other Lower Esophageal Sphincter Pressure and Gastric Emptying Cimetidine has no effect on lower esophageal sphincter (LES) pressure or the rate of gastric emptying. Pharmacokinetics Cimetidine is rapidly absorbed after oral administration and peak levels occur in 45 to 90 minutes. The half-life of cimetidine is approximately 2 hours.
Both oral and parenteral (I.V. or I.M.) administration provide comparable periods of therapeutically effective blood levels; blood concentrations remain above that required to provide 80% inhibition of basal gastric acid secretion for 4 to 5 hours following a dose of 300 mg. The principal route of excretion of cimetidine is the urine. Following parenteral administration, most of the drug is excreted as the parent compound; following oral administration, the…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cimetidine Hydrochloride Oral Solution is available as a clear yellow, orange-flavored solution as follows: 300 mg/5 mL 8 fl oz (237 mL) bottle NDC 62135-809-37 5 mL Unit Dose Cups NDC 62135-809-05 20 Unit Dose Cups of 5 mL each NDC 62135-809-24 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Rx Only Manufactured for Chartwell RX, LLC.
Congers, NY 10920 Rev. 01/2026 L71834
📋 Description ▾
DESCRIPTION Cimetidine is a histamine H 2 -receptor antagonist. Chemically it is N"-cyano-N-methyl-N'-[2-[[(5-methyl-1Himidazol-4-yl)methyl]thio]-ethyl],guanidine. The molecular formula for Cimetidine Hydrochloride, USP is C 10 H 16 N 6 S•HCl and the molecular weight is 288.80 the structural formula of Cimetidine Hydrochloride is: Cimetidine contains an imidazole ring, and is chemically related to histamine.
Cimetidine has a bitter taste and characteristic odor. Solubility Characteristics Cimetidine Hydrochloride is freely soluble in water, soluble in alcohol, very slightly soluble in chloroform and practically insoluble in ether. Each 5 mL (1 teaspoonful), for oral administration, contains Cimetidine Hydrochloride, equivalent to Cimetidine 300 mg; alcohol, 2.8%.
In addition, the oral solution contains the following inactive ingredients: consist of dibasic sodium phosphate, heptahydrate; FD&C Red #40; FD&C Yellow #6; hydrochloric acid; menthol; methylparaben; natural orange Wonf; poloxamer 188; propylene glycol; propylparaben; Prosweet liquid; sodium hydroxide; sodium saccharin dihydrate; sorbitol solution; and purified water. The pH range is 5.1 to 5.7. image description