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Dexamethasone .5 mg/5mL Elixir, 237 mL — NDC 64980-0509-24 package photo

Dexamethasone .5 mg/5mL Elixir, 237 mL

by Rising Pharma Holdings, Inc. · 237 mL in 1 BOTTLE, PLASTIC (64980-509-24)
NDC 64980-0509-24
🏷️ FDA NDC (as labeled) 64980-509-24 billing pads the product segment with a zero
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 →

🆔 Identity & classification

FDA NDC (as labeled) 64980-509-24
Product NDC 64980-509
11-digit billing NDC 64980050924
NCPDP billing unit ML — per mL (volume)
RxCUI 309686
UNII 7S5I7G3JQL
Application # ANDA090891
SPL Set ID 7cf5c17c-a80b-4547-83b2-0d53e2b933f7
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-08-01
Route ORAL
Dosage form ELIXIR
Substance DEXAMETHASONE
GPI-14 22100020001005
GPI class Dexamethasone
GCN Seq No 006780
GCN 27400
HICL code 002889
Ingredient (HICL) Dexamethasone
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P5
Therapeutic class — intermediate (HIC2) Adrenocortical Hormones
HIC3 code P5A
Therapeutic class — specific (HIC3) Glucocorticoids
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name DEXAMETHASONE 0.5 MG/5 ML ELX
FDB brand name Dexamethasone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 64980-509-24 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 64980-0509-24. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
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

LabelerRising Pharma Holdings, Inc.
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA090891 (ANDA)
Labeler code64980
First marketedAug 2011
Product typeHuman Prescription Drug
Portfolio525 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 DEXAMETHASONE 0.5 MG/5 ML ELX Ingredient Dexamethasone
📖 What it is MedlinePlus · NLM

Dexamethasone, a corticosteroid, is similar to a natural hormone produced by your adrenal glands. It often is used to replace this chemical when your body does not make enough of it. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders (e.g., colitis); severe allergies; and asthma. Dexamethasone is also used to treat certain types of cancer. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You're right that it treats a lot of conditions, and that can feel confusing. Dexamethasone is a corticosteroid, which is a type of anti-inflammatory medicine. Whether it's calming...
  • Why has my doctor prescribed dexamethasone — it seems to be used for so many different things?
  • Please don't stop it abruptly without talking to your doctor first, especially if you've been on it for more than a few days. Your body adjusts to having this medication on board,...
  • Can I just stop taking dexamethasone if I feel better or if I'm worried about side effects?
📖 Read our full Dexamethasone guide →
8
Nutrient depletion considerations

Dexamethasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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.

💊 What it looks like

Color Red
FlavorRaspberry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 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.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • 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.
  • 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.
  • 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 B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.

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 DailyMedingredient 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 $0.101 $24.01 / 237 ml
Medicaid paysCMS SDUD · 12 mo $0.1543 $36.57 / 237 ml
Medicare drug plans payPart D · Q2 2026 $0.0986 $23.37 / 237 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.119 $0.081
▼ Down 8% over the last 24 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
Dexamethasone .5 mg/5mL 62135-0114-37 Chartwell 237 ml $0.101 AA Availability likely
Dexamethasone .5 mg/5mLthis 64980-0509-24 Rising 237 ml $0.101 AA Availability likely
Dexamethasone .5 mg/5mL 70954-0872-10 ANI 1 bottle $0.101 AA Availability likely
Dexamethasone .5 mg/5mL 85742-0004-03 Kanchan 237 ml $0.101 AA Availability likely
Dexamethasone .5 mg/5mL 00054-3177-57 Hikma 240 ml $0.165 Availability likely +63%
Dexamethasone .5 mg/5mL 10135-0795-71 Marlex 237 ml AA FDA listed
Dexamethasone .5 mg/5mL 72162-2600-02 Bryant 237 ml AA FDA listed
Dexamethasone .5 mg/5mL 81033-0010-24 Kesin 20 cups AA 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

🏛️
2011
On the market since
Aug 2011
📍
2026
Currently FDA-listed
15 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 64980-0509-24, 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
31.4K
Units reimbursed last 4 qtrs
4M
Gross reimbursed last 4 qtrs
$623.8K
Avg / prescription
$19.87
Avg / unit
$0.1543
Latest quarter Q4 2025
9.9KRx
Medicaid pays / mL
$0.1543
gross reimbursed
vs
NADAC / mL
$0.1013
acquisition cost
=
Spread
+$0.0530
+52% 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
19% FFS 81% MCO
Fee-for-service · 5,936 Rx Managed care · 25,462 Rx
State Medicaid map
Alaska: 1,421 units · 194 per 100k residents AK Maine: 18,166 units · 1,302 per 100k residents ME Washington: 95,836 units · 1,227 per 100k residents WA Idaho: 19,985 units · 1,018 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 59,189 units · 1,032 per 100k residents MN Wisconsin: 42,151 units · 713 per 100k residents WI Michigan: 247,276 units · 2,464 per 100k residents MI New York: 118,727 units · 607 per 100k residents NY Vermont: 11,667 units · 1,803 per 100k residents VT New Hampshire: 3,007 units · 214 per 100k residents NH Oregon: 60,579 units · 1,431 per 100k residents OR Nevada: 30,014 units · 940 per 100k residents NV Wyoming: no data reported WY South Dakota: 5,852 units · 637 per 100k residents SD Iowa: 28,722 units · 896 per 100k residents IA Illinois: 125,817 units · 1,003 per 100k residents IL Indiana: 65,910 units · 961 per 100k residents IN Ohio: 139,012 units · 1,180 per 100k residents OH Pennsylvania: 143,068 units · 1,104 per 100k residents PA New Jersey: 60,160 units · 648 per 100k residents NJ Massachusetts: 89,891 units · 1,284 per 100k residents MA California: 472,692 units · 1,213 per 100k residents CA Utah: 24,855 units · 727 per 100k residents UT Colorado: 89,130 units · 1,516 per 100k residents CO Nebraska: 22,380 units · 1,131 per 100k residents NE Missouri: 61,661 units · 995 per 100k residents MO Kentucky: 51,433 units · 1,136 per 100k residents KY West Virginia: 19,131 units · 1,081 per 100k residents WV Virginia: 58,312 units · 669 per 100k residents VA Maryland: 52,785 units · 854 per 100k residents MD Connecticut: 38,394 units · 1,061 per 100k residents CT Rhode Island: 14,833 units · 1,355 per 100k residents RI Arizona: 67,299 units · 906 per 100k residents AZ New Mexico: 19,735 units · 934 per 100k residents NM Kansas: 13,902 units · 473 per 100k residents KS Arkansas: 12,608 units · 411 per 100k residents AR Tennessee: 31,738 units · 445 per 100k residents TN North Carolina: 100,460 units · 927 per 100k residents NC South Carolina: 33,816 units · 629 per 100k residents SC Delaware: 3,217 units · 312 per 100k residents DE Oklahoma: 36,135 units · 892 per 100k residents OK Louisiana: 3,142 units · 68.7 per 100k residents LA Mississippi: 9,998 units · 340 per 100k residents MS Alabama: 17,415 units · 341 per 100k residents AL Georgia: 59,178 units · 537 per 100k residents GA D.C.: no data reported DC Hawaii: 9,616 units · 670 per 100k residents HI Texas: 74,813 units · 245 per 100k residents TX Florida: 63,105 units · 279 per 100k residents FL
Units reimbursed · per 100k residents
68.72,464
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 Michigan 2,464 /100k
2 Vermont 1,803 /100k
3 Colorado 1,516 /100k
4 Oregon 1,431 /100k
5 Rhode Island 1,355 /100k
6 Maine 1,302 /100k
7 Massachusetts 1,284 /100k
8 Washington 1,227 /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.

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

Medicare Part D (outpatient prescription) spending for Dexamethasone — the program that covers self-administered drugs. 17 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 Dexamethasone. 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
$4.52M
Claims incl. refills
379.2K
Beneficiaries
287.4K
Spend / beneficiary
$15.74
Spend / claim
$11.92
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dexamethasone — the ingredient across all brands.

Top reported reactions

Fatigue17,772
Diarrhoea17,597
Nausea14,727
Plasma Cell Myeloma14,363
Pneumonia14,122
Death13,772
Neutropenia11,944

Age at onset

Neonate725
Infant410
Child1,670
Adolescent801
Adult25,864
Elderly28,087

Reporter sex

308,307 reports

Serious outcomes

Death49,539
Life-threatening22,963
Disabling6,508
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 30,273 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
64980-0509-24 You're viewing this 237 mL in 1 BOTTLE, PLASTIC (64980-509-24) 2011-08-01 Active

📄 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 ~2 min read

INDICATIONS AND USAGE Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Acute rheumatic carditis Dermatologic Diseases: Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia Respiratory Diseases: Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis Hematologic Disorders: Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases : For palliative management of: Leukemia and lymphomas in adults Acute leukemia of childhood Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases: To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement Diagnostic testing of adrenocortical hyperfunction.

⏱️ Dosage and Administration ~2 min read

DOSAGE & ADMINISTRATION For oral administration: DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT. The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.75 mg may suffice, while in severe diseases doses higher than 9 mg may be required.

The initial dosage should be maintained or adjusted until the patient’s response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue Dexamethasone Elixir and transfer the patient to other therapy. After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.

Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily. If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually.

The following milligram equivalents facilitate changing to Dexamethasone Elixir from other glucocorticoids: Dexamethasone Elixir Methylprednisolone and Triamcinolone Prednisolone and Prednisone Hydrocortisone Cortisone 0.75 mg = 4 mg = 5 mg = 20 mg = 25 mg Dexamethasone suppression tests 1. Tests for Cushing’s syndrome. Give 1 mg of Dexamethasone orally at 11:00 p.m.

Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

2. Test to distinguish Cushing’s syndrome due to pituitary ACTH excess from Cushing’s syndrome due to other causes. Give 2 mg of Dexamethasone orally every 6 hours for 48 hours.

Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

Contraindications 8 words

CONTRAINDICATIONS Systemic fungal infections Hypersensitivity to this product

⚠️ Warnings ~2 min read

WARNINGS In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including Dexamethasone Elixir, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteriods can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Incease the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteriod-associated infections can be mild but can be severe and at times fatal.

The rate of infectious complications increases with increasing corticosteriod dosages. Monitor for the development of infection and consider Dexamethasone Elixir withdrawal or dosage reduction as needed. Tuberculosis If Dexamethasone Elixir is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.

Closely monitor such patients for reactivation. During prolonged Dexamethasone Elixir therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteriods, including Dexamethasone Elixir.

In corticosteriod-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If a Dexamethasone Elixir-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a Dexamethasone Elixir-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

Hepatitis B Virus Reactivation Hepatitis B Virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteriods, including Dexamethasone Elixir. Reactivation can also occur infrequently in corticosteriod-treated patients who appear to have resolved hepatitis B infection. Screen patients for hepatitis B infection before intiating immunosuppressive (e.g., prolonged) treatment with Dexamethasone Elixir.

For patients who show evidence of hepatitis B infection, recommend consultation with physcians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Fungal Infections Corticosteriods, including Dexamethasone Elixir, may exacerbate systemic fungal infections; therefore, avoid Dexamethasone Elixir use in the presence of such infections unless Dexamethasone Elixir is needed to control drug reactions. For patients on chronic Dexamethasone Elixir therapy who develop systemic fungal infections, Dexamethasone Elixir withdrawal or dosage reduction is recommended.

Amebiasis Corticosteriods , including Dexamethasone Elixir, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before intiating Dexamethasone Elixir in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteriods, including Dexamethasone Elixir, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.

In such patients, cortcosteriod-induced immunosupression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Cerebral Malaria Avoid corticosteriods, including Dexamethasone Elixir, in patients with cerebral malaria. Kaposi's Sarcoma Kaposi's Sarcoma has been reported to occur in patients receiving corticoste…

🤒 Adverse Reactions 203 words

ADVERSE REACTIONS Fluid and Electrolyte Disturbances: Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal: Muscle weakness Steroid myopathy Osteoporosis Aseptic necrosis of femoral and humeral heads Vertebral compression fractures Loss of muscle mass Pathologic fracture of long bones Tendon rupture Gastrointestinal: Pancreatitis Abdominal distention Peptic ulcer with possible perforation and hemorrhage Ulcerative esophagitis Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease Dermatologic: Impaired wound healing Thin fragile skin Erythema May suppress reactions to skin tests Petechiae and ecchymoses Increased sweating Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema Neurologic: Convulsions Vertigo Headache Psychic Disturbances Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Endocrine: Menstrual irregularities Development of cushingoid state Manifestations of latent diabetes mellitus Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness Decreased carbohydrate tolerance Suppression of growth in children Increased requirements for insulin or oral hypoglycemic agents in diabetes Hirsutism Ophthalmic: Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic: Negative nitrogen balance due to protein catabolism Cardiovascular: Myocardial rupture following recent myocardial infarction (See WARNINGS) Other: Hypersensitivity Thromboembolism Weight gain Increased appetite Nausea Malaise Hiccups

🆘 Overdosage 40 words

OVERDOSAGE Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic. The oral LD 50 of dexamethasone in female mice was 6.5 g/kg.

🧬 Clinical Pharmacology 78 words

CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids, (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects.

In addition, they modify the body’s immune responses to diverse stimuli. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

📦 How Supplied / Storage and Handling 178 words

HOW SUPPLIED Dexamethasone Elixir, USP 0.5 mg/5 mL is supplied as a clear, red, raspberry-flavored liquid in the following size: 8 fl oz (237 mL) bottle (NDC 64980-509-24) RECOMMENDED STORAGE Store at 20˚-25˚C (68˚-77˚F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight container as defined in the USP. Rx Only Manufactured for: Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 Revised : 08/2025 PIR50924-00 Each 5 mL (teaspoonful) contains: Dexamethaosne, USP....................................................................................................0.5 mg Also contains: Benzoic Acid, USP (as preservative)................................................................................0.1% Alcohol (%v/v)............................................................................................................5.1% USUAL ADULT DOSAGE: See accompanying package insert.

WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Store at 20º – 25ºC (68º – 77ºF) [see USP Controlled Room Temperature].

KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight container as defined in the USP. Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Lyne Laboratories, Inc.

Brockton, MA 02301 Revised: 08/2025 LR50924-00

📋 Description 212 words

DESCRIPTION Each 5 mL (teaspoonful) contains: Dexamethasone, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg Also contains: Benzoic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.1% (as preservative) Alcohol (% v/v) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.1% Inactive Ingredients: artificial raspberry flavor; citric acid; FD&C red no. 40; sucrose; propylene glycol and purified water. It may also contain sodium citrate dihydrate.

Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air.

It is practically insoluble in water. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione.

The molecular formula is C 22 H 29 FO 5 and the structural formula is: structure

💬 Information for Patients 38 words

Information for Patients: Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.