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Famotidine 40 mg/5mL Powder, For Suspension, 50 mL — NDC 00832-6045-50 package photo

Famotidine 40 mg/5mL Powder, For Suspension, 50 mL

by Upsher-Smith Laboratories, LLC · 50 mL in 1 BOTTLE (0832-6045-50)
NDC 00832-6045-50
🏷️ FDA NDC (as labeled) 0832-6045-50 billing pads the labeler segment with a zero
This package
Contains50 mL Cost per mL$0.1312 NADAC Per package$6.56 / 50 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.4451/unit · Part D plans $0.6788/unit — full pricing hub ↓
Also comes in: 100 ml 00832-6045-10 150 ml 00832-6045-15
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 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

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

⚠️
Other active recalls for Famotidine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0809-2026
Class I · Nov 6, 2025 — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. (Fresenius Kabi USA, LLC) · FDA recall D-0182-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0832-6045-50
Product NDC 0832-6045
11-digit billing NDC 00832604550
NCPDP billing unit ML — per mL (volume)
RxCUI 310274
UNII 5QZO15J2Z8
Application # ANDA217655
SPL Set ID d528fadf-316f-4fea-9bec-070c01f80d64
Established class (EPC) Histamine-2 Receptor Antagonist
Mechanism of action Histamine H2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-16
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance FAMOTIDINE
GCN Seq No 011676
GCN 45960
HICL code 004521
Ingredient (HICL) Famotidine
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2D
Therapeutic class — specific (HIC3) Histamine H2-Receptor Inhibitors
AHFS code 04:92.00.00
AHFS class Other Antihistamines
FDB label name FAMOTIDINE 40 MG/5 ML SUSP
FDB brand name Famotidine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0832-6045-50 — a 4-4-2 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 labeler segment → 00832-6045-50. 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.

🏷️ RxNorm drug class

This medicine belongs to the Histamine-2 Receptor Antagonist class.

Pharmacologic class Histamine-2 Receptor Antagonist
Drug family (ATC) H2-receptor antagonists
How it works Histamine H2 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerUpsher-Smith Laboratories, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA217655 (ANDA)
Labeler code00832
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio228 products on file
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

Label name FAMOTIDINE 40 MG/5 ML SUSP Ingredient Famotidine
📖 What it is MedlinePlus · NLM

Famotidine injection is used in people who are hospitalized to treat certain conditions in which the stomach produces too much acid or to treat ulcers (sores in the lining of the stomach or intestine) that were not successfully treated with other medications. Famotidine injection is also used on a short-term basis in people who cannot take oral medication to treat ulcers, to prevent ulcers from returning after they have healed, to treat gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube betwe...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Great question. Antacids (like Tums) neutralize acid that's already in your stomach — they work fast but don't last long. Famotidine is different: it actually blocks a signal in yo...
  • What exactly does famotidine do — and how is it different from antacids?
  • The over-the-counter tablets are meant to relieve heartburn when it happens, or to prevent it if you take them 10 to 60 minutes before a meal that usually causes trouble. You shoul...
  • Can I take the OTC version whenever I have heartburn, or is there a limit?
📖 Read our full Famotidine guide →
6
Nutrient depletion considerations

Famotidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Famotidine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 88XHZ13131
    Fumaric acid is an organic acid used in medications as a buffer and pH regulator. It helps maintain the proper acidity level in the medicine and may aid in tablet disintegration.
  • UNII CR6K9C2NHK
    A synthetic preservative derived from methylparaben. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • 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.
  • UNII 625NNB0G9N
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.131 $6.56 / 50 ml
Medicaid paysCMS SDUD · 12 mo $0.4451 $22.26 / 50 ml
Medicare drug plans payPart D · Q2 2026 $0.6788 $33.94 / 50 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.622 $0.131
▼ Down 77% over the last 12 months.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Famotidine 40 mg/5mL 72205-0233-84 Novadoz 55 ml $0.078 AB Availability likely save 41%
Famotidine 40 mg/5mLthis 00832-6045-50 Upsher-Smith 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 27241-0249-49 Ajanta 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 31722-0063-31 Camber 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 42571-0433-45 Micro 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 59651-0701-50 Aurobindo 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 60219-2090-04 Amneal 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 67877-0775-89 Ascend 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 68180-0150-01 Lupin 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 68382-0444-05 Zydus 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 69238-2090-04 Amneal 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 70377-0113-11 Biocon 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 70954-0316-10 ANI 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 72603-0171-01 NorthStar 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 80005-0119-16 Carnegie 50 ml $0.131 AB Availability likely —
Famotidine 40 mg/5mL 00527-5190-80 Lannett 55 ml — AB FDA listed —
Famotidine 40 mg/5mL 43386-0500-11 Lupin 50 ml — AB FDA listed —
Famotidine 40 mg/5mL 43598-0572-11 DR. 50 ml — AB FDA listed —
Famotidine 40 mg/5mL 51407-0452-50 Golden 50 ml — AB FDA listed —
famotidine 40 mg/5mL 68475-0400-01 Navinta 50 ml — AB FDA listed —
Famotidine 40 mg/5mL 72162-2599-02 Bryant 50 ml — AB FDA listed —
Famotidine 40 mg/5mL 64980-0737-50 RISING 50 ml — AB FDA listed —
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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00832-6045-50, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
26.5K
Units reimbursed last 4 qtrs
1.9M
Gross reimbursed last 4 qtrs
$841K
Avg / prescription
$31.74
Avg / unit
$0.4451
Latest quarter Q4 2025
5.1KRx
Medicaid pays / mL
$0.4451
gross reimbursed
vs
NADAC / mL
$0.1312
acquisition cost
=
Spread
+$0.3139
+239% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 8,852 Rx Managed care · 17,643 Rx
State Medicaid map
Alaska: no data reported AK Maine: 8,650 units · 620 per 100k residents ME Washington: 11,000 units · 141 per 100k residents WA Idaho: 3,300 units · 168 per 100k residents ID Montana: no data reported MT North Dakota: 700 units · 89.4 per 100k residents ND Minnesota: 13,750 units · 240 per 100k residents MN Wisconsin: 12,350 units · 209 per 100k residents WI Michigan: 28,365 units · 283 per 100k residents MI New York: 137,605 units · 703 per 100k residents NY Vermont: 3,750 units · 580 per 100k residents VT New Hampshire: 4,411 units · 315 per 100k residents NH Oregon: 600 units · 14.2 per 100k residents OR Nevada: 2,150 units · 67.3 per 100k residents NV Wyoming: no data reported WY South Dakota: 650 units · 70.7 per 100k residents SD Iowa: 5,300 units · 165 per 100k residents IA Illinois: 15,440 units · 123 per 100k residents IL Indiana: 6,502 units · 94.8 per 100k residents IN Ohio: 33,905 units · 288 per 100k residents OH Pennsylvania: 59,936 units · 462 per 100k residents PA New Jersey: 57,285 units · 617 per 100k residents NJ Massachusetts: 161,568 units · 2,308 per 100k residents MA California: 90,532 units · 232 per 100k residents CA Utah: 850 units · 24.9 per 100k residents UT Colorado: 4,300 units · 73.2 per 100k residents CO Nebraska: 1,950 units · 98.6 per 100k residents NE Missouri: 15,850 units · 256 per 100k residents MO Kentucky: 63,223 units · 1,397 per 100k residents KY West Virginia: 11,320 units · 640 per 100k residents WV Virginia: 119,370 units · 1,370 per 100k residents VA Maryland: 32,415 units · 525 per 100k residents MD Connecticut: 91,350 units · 2,526 per 100k residents CT Rhode Island: 31,450 units · 2,872 per 100k residents RI Arizona: no data reported AZ New Mexico: 1,601 units · 75.7 per 100k residents NM Kansas: 5,700 units · 194 per 100k residents KS Arkansas: 27,100 units · 884 per 100k residents AR Tennessee: 86,350 units · 1,212 per 100k residents TN North Carolina: 169,000 units · 1,560 per 100k residents NC South Carolina: 147,950 units · 2,754 per 100k residents SC Delaware: 11,100 units · 1,077 per 100k residents DE Oklahoma: 4,750 units · 117 per 100k residents OK Louisiana: 8,206 units · 179 per 100k residents LA Mississippi: 31,238 units · 1,063 per 100k residents MS Alabama: 27,050 units · 530 per 100k residents AL Georgia: 174,800 units · 1,585 per 100k residents GA D.C.: 5,200 units · 766 per 100k residents DC Hawaii: no data reported HI Texas: 40,800 units · 134 per 100k residents TX Florida: 15,710 units · 69.5 per 100k residents FL
Units reimbursed · per 100k residents
14.22,872
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Rhode Island 2,872 /100k
2 South Carolina 2,754 /100k
3 Connecticut 2,526 /100k
4 Massachusetts 2,308 /100k
5 Georgia 1,585 /100k
6 North Carolina 1,560 /100k
7 Kentucky 1,397 /100k
8 Virginia 1,370 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
5 ml this page00832-6045-50 26,495 Rx · $841,028
15 ml00832-6045-15 289 Rx · $16,168
1 ml00832-6045-10 231 Rx · $14,630
Drug total (last 4 qtrs): 27,015 Rx · 1,955,912 units · $871,826 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Famotidine — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Famotidine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$40.22M
Claims incl. refills
3.8M
Beneficiaries
2.6M
Spend / beneficiary
$15.35
Spend / claim
$10.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00832-6045-10 100 mL in 1 BOTTLE (0832-6045-10) $0.4942 / mL $49.42 2023-10-27 Active
00832-6045-15 150 mL in 1 BOTTLE (0832-6045-15) $0.2803 / mL $42.05 2023-10-27 Active
00832-6045-50 You're viewing this 50 mL in 1 BOTTLE (0832-6045-50) $0.1312 / mL $6.56 2023-07-11 Active

You're viewing the smallest of 3 pack sizes for this product.

This pack has the lowest per-mL cost of the 3 priced pack sizes ($0.1312 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 98% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00832-6045-50?
NDC 00832-6045-50 contains 50 mL — 50 ml in 1 bottle.
What is the difference between NDC 00832-6045-50 and NDC 00832-6045-10?
Both are Famotidine 40 mg/5mL Powder, For Suspension — the drug itself is identical. NDC 00832-6045-50 is the 50 mL package, while NDC 00832-6045-10 is the 100 ml package. Per-mL NADAC also differs: $0.1312 here vs $0.4942 for the 100 ml pack.
What NDC number is used to bill for this package of Famotidine 40 mg/5mL Powder, For Suspension?
Bill NDC 00832-6045-50 — the 11-digit billing format is 00832604550. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

📄 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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 210 words ▾

1 INDICATIONS AND USAGE Famotidine for oral suspension is indicated in adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: peptic ulcer disease.

GERD with or without esophagitis and ulcerations. Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of: GERD. Famotidine for oral suspension is a histamine-2 (H 2 ) receptor antagonist indicated ( 1 ): In adults for the treatment of: active duodenal ulcer (DU) active gastric ulcer (GU) symptomatic nonerosive gastroesophageal reflux disease (GERD) erosive esophagitis due to GERD, diagnosed by biopsy treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias) reduction of the risk of DU recurrence In pediatric patients 1 year of age and older for the treatment of: peptic ulcer GERD with or without esophagitis and ulcerations In pediatric patients from birth to less than 1 year of age for the treatment of: GERD

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended adult dosage by indication ( 2.1 ): Active DU 40 mg once daily; or 20 mg twice daily Active GU 40 mg once daily Symptomatic Nonerosive GERD 20 mg twice daily Erosive Esophagitis due to GERD 20 mg twice daily; or 40 mg twice daily Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily Recommended pediatric dosage by indication ( 2.2 ): Peptic Ulcer Disease 1 year to less than 17 years Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily; may increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily; Maximum of 40 mg per day GERD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily; may increase to 1 mg/kg once daily; 3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily; may increase to 1 mg/kg twice daily; Maximum of 40 mg per day GERD with or without esophagitis and ulcerations 1 year to less than 17 years 0.5 mg/kg twice daily Maximum of 40 mg twice daily See full prescribing information for complete dosing information in adults and pediatrics, recommended treatment duration by indication, and dosage adjustment for adult patients with renal impairment.

( 2.1 , 2.2 , 2.3 ) Administration ( 2.3 ) : Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.

2.1Recommended Dosage in Adults The recommended dosage and duration of famotidine for oral suspension, USP in adults with normal renal function is shown in Table 1. Table 1: Recommended Dosage and Duration of Famotidine for Oral Suspension After preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL [See Dosage and Administration (2.3)] . , USP in Adults with Normal Renal Function Indication Recommended Dosage Recommended Duration Active DU 40 mg once daily; or 20 mg twice daily Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14)] . .

Up to 8 weeks In clinical trials, the majority of patients healed within 4 weeks. For patients who do not heal after 4 weeks, consider an additional 2 to 4 weeks of treatment [see Clinical Studies (14.1)] . , Longer treatment durations have not been studied in clinical trials [see Clinical Studies (14.1, 14.2, 14.3)] . Active GU 40 mg once daily.

Up to 8 weeks Symptomatic nonerosive GERD 20 mg twice daily. Up to 6 weeks Erosive esophagitis due to GERD, diagnosed by endoscopy 20 mg twice daily; or 40 mg twice daily . Up to 12 weeks Pathological hypersecretory conditions Starting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs.

Maximum dosage 160 mg every 6 hours. As clinically indicated Reduction of the risk of DU recurrence 20 mg once daily. 1 year , or as clinically indicated

2.2Recommended Dosage in Pediatric Patients The recommended dosage and duration of famotidine for oral suspension, USP in pediatric patients with normal renal function is shown in Table 2. Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension, USP in Pediatric Patients with Normal Renal Function Indication Pediatric Age Range Recommended Dosage After preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL [See Dosage and Administration (2.3)] . Duration Peptic Ulcer Disease 1 year to less than 17 years Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily.

May increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily. Maximum of 40 mg per day. 8 weeks Treatment duration based on adult recommendations (see Table 1) .

Individualize the dose and duration based upon clinical response and/or pH determinations (gastric or esophageal) and endoscopy. GERD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily .

Up to 8 weeks , Use conservative measures (e.g., thickened feedings) concurrently [see Use in Specific Populations (8.4)] . , After 4 weeks of treatment re…

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS Famotidine for oral suspension 400 mg, 800 mg and 1,200 mg is a white to off-white powder containing 40 mg of famotidine per 5 mL. When constituted as directed, famotidine for oral suspension is a smooth, mobile, white to off-white, homogeneous suspension with a cherry-banana-mint flavor, For oral suspension: 40 mg/5 mL ( 3 )

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS Famotidine for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 receptor antagonists. ( 4 )

⚠️ Warnings and Cautions 181 words ▾

5 WARNINGS AND PRECAUTIONS Central Nervous System (CNS) Adverse Reactions : Elderly patients and patients with renal impairment at increased risk; reduce the dosage. ( 2.2 , 5.1 , 8.5 , 8.6 ) GI Malignancy : Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. ( 5.2 )

5.1Central Nervous System Adverse Reactions Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ] .

5.2Concurrent Gastric Malignancy In adults, symptomatic response to therapy with famotidine for oral suspension does not preclude the presence of gastric malignancy. Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine for oral suspension.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial 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 the clinical trials of another drug and may not reflect the rates observed in practice. The safety of famotidine for oral suspension has been established based on adequate and well-controlled studies of another oral famotidine product [see Clinical Studies (14) ] . The following is a summary of the adverse reactions reported in those studies.

Oral famotidine was studied in 7 U.S. and international placebo- and active-controlled trials in approximately 2,500 patients [see Clinical Studies (14) ] . A total of 1,442 patients were treated with famotidine, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily. The population was 17 to 91 years old, fairly well distributed between sex and race; however, the predominant race was Caucasian.

The following adverse reactions occurred in greater than or equal to 1% of famotidine-treated patients: headache, dizziness and constipation. The following other adverse reactions were reported in less than 1% of patients in clinical trials: Body as a Whole: fever, asthenia, fatigue Cardiovascular: palpitations Gastrointestinal: elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: thrombocytopenia Hypersensitivity: orbital edema, rash, conjunctival injection, bronchospasm Musculoskeletal: musculoskeletal pain, arthralgia Nervous System/Psychiatric: seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence Skin: pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: impotence Pediatric Patients Less Than One Year of Age In a clinical study in 35 pediatric patients less than 1 year of age with GERD symptoms, two patients discontinued due to adverse reactions.

Agitation observed in 5 patients resolved when famotidine was discontinued [see Use in Specific Populations (8.4) ] .

6.2Post marketing Experience The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, AV block, prolonged QT interval Gastrointestinal: cholestatic jaundice, hepatitis Hematologic: agranulocytosis, pancytopenia, leukopenia Hypersensitivity: anaphylaxis, angioedema, facial edema, urticaria Musculoskeletal: rhabdomyolysis, muscle cramps Nervous System/Psychiatric: confusion, agitation, paresthesia Respiratory: interstitial pneumonia Skin: toxic epidermal necrolysis/Stevens-Johnson syndrome

🔄 Drug Interactions 199 words ▾

7 DRUG INTERACTIONS Drugs Dependent on Gastric pH for Absorption : Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. See full prescribing information for a list of interacting drugs. ( 7.1 ) Tizanidine (CYP1A2) Substrate : Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness; avoid concomitant use, if possible. ( 7.2 )

7.1Drugs Dependent on Gastric pH for Absorption Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity, leading to loss of efficacy of the concomitant drug. Concomitant administration of famotidine for oral suspension with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended. See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine.

7.2Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate. Avoid concomitant use with famotidine for oral suspension. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness. Refer to the full prescribing information for tizanidine.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric Use : Use the lowest effective dose for an elderly patient and monitor renal function. ( 2.2 , 5.1 , 8.5 ) Renal Impairment : Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage in adults. ( 2.2 , 8.6 )

8.1Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data ) . The estimated background risk for 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2,000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine.

While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.2Lactation Risk Summary There are limited data available on the presence of famotidine in human breast milk. There were no effects on the breastfed infant. There are no data on famotidine effects on milk production.

Famotidine is present in the milk of lactating rats (see Data ) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for famotidine and any potential adverse effects on the breastfed child from famotidine for oral suspension or from the underlying maternal condition. Data Animal Data Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose.

8.4Pediatric Use Peptic Ulcer Disease and GERD With or Without Esophagitis and Ulcerations Pediatric Patients One Year to Less than 17 Years of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients 1 year to less than 17 years of age for the treatment of peptic ulcer disease and GERD with or without esophagitis and ulcerations. Use of famotidine in this age group is supported by evidence from adequate and well-controlled studies of famotidine in adults with additional pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2 , 12.3) ] .

The safety and effectiveness of famotidine for oral suspension for the treatment of peptic ulcer disease in pediatric patients less than one year of age have not been established. GERD Pediatric Patients Less Than One Year of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients from birth to less than 1 year of age for the treatment of GERD. The use of famotidine this is age group is supported by evidence from adequate and well-controlled studies of famotidine in ad…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see Data ) . The estimated background risk for 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2,000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine.

While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Peptic Ulcer Disease and GERD With or Without Esophagitis and Ulcerations Pediatric Patients One Year to Less than 17 Years of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients 1 year to less than 17 years of age for the treatment of peptic ulcer disease and GERD with or without esophagitis and ulcerations. Use of famotidine in this age group is supported by evidence from adequate and well-controlled studies of famotidine in adults with additional pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2 , 12.3) ] .

The safety and effectiveness of famotidine for oral suspension for the treatment of peptic ulcer disease in pediatric patients less than one year of age have not been established. GERD Pediatric Patients Less Than One Year of Age The safety and effectiveness of famotidine for oral suspension have been established in pediatric patients from birth to less than 1 year of age for the treatment of GERD. The use of famotidine this is age group is supported by evidence from adequate and well-controlled studies of famotidine in adults and with supportive data in pediatric patients from birth to less than 1 year of age [see Dosage and Administration (2.1) , Clinical Pharmacology (12.2 , 12.3) , Clinical Studies (14.7) ] .

Other Conditions The safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established in pediatric patients. A safe and effective dosage has not been established in pediatric patients with renal impairment.

🧓 Geriatric Use 129 words ▾

8.5Geriatric Use Of the 1,442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. In post marketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [see Warnings and Precautions (5.1) ] .

Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine for oral suspension may be greater in elderly patients, particularly those with impaired renal function [see Use in Specific Populations (8.6) ] . In general, use the lowest effective dose of famotidine for oral suspension for an elderly patient and monitor renal function [see Dosage and Administration (2.2) ] .

🆘 Overdosage 87 words ▾

10 OVERDOSAGE The types of adverse reactions in overdosage of famotidine are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions (6.1) ] . In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.

Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis. There is limited experience on the usefulness of hemodialysis as a treatment for famotidine overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine-2 (H 2 ) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.

12.2Pharmacodynamics Adults Famotidine inhibited both basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration of famotidine, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose-dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 mg and 40 mg was 10 hours to 12 hours.

Single evening oral doses of 20 mg and 40 mg inhibited basal and nocturnal acid secretion in all subjects; mean nocturnal gastric acid secretion was inhibited by 86% and 94%, respectively, for a period of at least 10 hours. The same doses given in the morning suppressed food-stimulated acid secretion in all subjects. The mean suppression was 76% and 84%, respectively, 3 to 5 hours after administration, and 25% and 30%, respectively, 8 to 10 hours after administration.

In some subjects who received the 20 mg dose, however, the antisecretory effect was dissipated within 6 hours to 8 hours. There was no cumulative effect with repeated doses. The nocturnal intragastric pH was raised by evening doses of 20 mg and 40 mg of famotidine to mean values of 5.0 and 6.4, respectively.

When famotidine was given after breakfast, the basal daytime interdigestive pH at 3 and 8 hours after 20 mg or 40 mg of famotidine was raised to about 5. Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine.

In clinical pharmacology studies, systemic effects of famotidine in the CNS, cardiovascular, respiratory, or endocrine systems were not noted. Also, no anti-androgenic effects were noted. Serum hormone levels, including prolactin, cortisol, thyroxine (T 4 ), and testosterone, were not altered after treatment with famotidine.

Pediatric Patients Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 years to 13 years of age using the sigmoid E max model. These data suggest that the relationship between serum concentration of famotidine and gastric acid suppression is similar to that observed in adults (see Table 4 ). Table 4: Serum Concentrations of Famotidine Associated with Gastric Acid Reduction in Famotidine-Treated Pediatric and Adult Patients EC 50 (ng/mL) Using the Sigmoid E max model, serum concentrations of famotidine associated with 50% maximum gastric acid reduction are presented as means ± SD.

Pediatric Patients 26 ± 13 Adults Healthy adult subjects 26.5 ±

10.3Adult patients with upper GI bleeding 18.7 ±

10.8In a study examining the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients, four pediatric patients ages 11 to 15 years of age using the oral formulation at a dose of 0.5 mg/kg, maintained a gastric pH above 5 for 13.5 ± 1.8 hours.

12.3Pharmacokinetics Absorption Famotidine is incompletely absorbed. The bioavailability of oral doses is 40% to 45%. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.

Peak famotidine plasma levels occur in 1 to 3 hours. Plasma levels after multiple dosages are similar to those after single doses. Distribution Fifteen to 20% of famotidine in plasma is protein bound.

Elimination Metabolism Famotidine undergoes minimal first-pass metabolism. Twenty-five to 30% of an oral dose was recovered in the urine as unchanged compound. The only metabolite identified in humans is the S-oxide.

Excretion Famotidine has an elimination half-life of 2.5 to…

🧬 Mechanism of Action 51 words ▾

12.1Mechanism of Action Famotidine is a competitive inhibitor of histamine-2 (H 2 ) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.

📦 How Supplied / Storage and Handling 122 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Famotidine for oral suspension, USP 40 mg/5 mL is supplied as follows: NDC Amount of Famotidine Quantity when reconstituted Description 0832-6045-50 0832-6045-10 0832-6045-15 400 mg 800 mg 1,200 mg 50 mL 100 mL 150 mL White to off-white powder. When constituted as directed, famotidine suspension is a smooth, mobile, off-white, homogeneous suspension with a cherry-banana-mint flavor. Prior to dispensing, constitute famotidine for oral suspension, USP [see Dosage and Administration (2.3) ] .

Storage Store famotidine for oral suspension dry powder and constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Discard unused constituted suspension after 30 days.

Dispense in a USP tight, light-resistant container.

📦 Storage and Handling 45 words ▾

Storage Store famotidine for oral suspension dry powder and constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Discard unused constituted suspension after 30 days. Dispense in a USP tight, light-resistant container.

📋 Description 149 words ▾

11 DESCRIPTION The active ingredient in famotidine for oral suspension, USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine, USP is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine, USP is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.43.

Its structural formula is: Each 5 mL of famotidine for oral suspension, USP when prepared as directed contains 40 mg of famotidine, USP and the following inactive ingredients: carboxymethyl cellulose sodium, flavors (banana, cherry and peppermint), fumaric acid, microcrystalline cellulose, sucrose, xanthan gum. Added as preservatives are sodium benzoate 0.42%, sodium methyl paraben 0.08%, and sodium propyl paraben 0.02%. Famotidine, USP is a white to pale yellow-white crystalline compound that is freely soluble in dimethylformamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol, chloroform, ether and in ethyl acetate.

Chemical Structure

💬 Information for Patients 136 words ▾

17 PATIENT COUNSELING INFORMATION Central Nervous System (CNS) Adverse Reactions Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see Warnings and Precautions (5.1) ] . Report symptoms immediately to a healthcare provider. QT Prolongation Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see Use in Specific Populations (8.6) ] .

Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider. Administration Advise patients to take and caregivers to administer: Famotidine once daily before bedtime or twice daily in the morning and before bedtime, as recommended. Advise patients and caregivers: Famotidine may be taken with or without food.

Famotidine may be given with antacids.

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