Hydroxyzine Hydrochloride 50 mg Tablet, Film Coated, 500-count — NDC 16571-115-50 (Billing 16571-0115-50)
This is a package of 500 tablets of Hydroxyzine Hydrochloride 50 mg Tablet, Film Coated from Rising Pharma Holdings, Inc., marketed since Aug 2023 and currently FDA-listed; retail pharmacies pay about $0.0558 per tablet (NADAC). It is the main listing for this product, which comes in 3 package sizes.
Other active recalls for Hydroxyzine Hydrochloride (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003729
- GCN: 13944
- GPI-14 (Medi-Span): 57200040100315
- HICL (First Databank): 001608
- AHFS class code: 04:04.00.00
- RxCUI (RxNorm): 995218
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antihistamine class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Hydroxyzine is used to relieve itching caused by allergic skin reactions, to relieve anxiety and tension, and as a sedative before and after general anesthesia for surgery. Hydroxyzine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. It also works by decreasing activity in the brain.
Read the full MedlinePlus article ↗- Taken by mouth, it's used for anxiety and tension, itching from allergic skin conditions like hives and eczema, and sedation around anesthesia. The injection has additional uses in...
- It can. Drowsiness is the most common effect, though it often fades in a few days or with a lower dose. Don't drive or use dangerous machinery until you know how it affects you.
- It's best not to. Hydroxyzine can strengthen alcohol, narcotics, barbiturates and other sedating drugs. Tell your prescriber about everything you take, since doses of some may need...
- Can I drink alcohol or take other sedating medicines with it?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.056 | $27.90 / 500 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1774 | $88.70 / 500 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1378 | $68.90 / 500 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 16571-0115-01 16571-115-01 | 100 TABLET, FILM COATED in 1 BOTTLE | $0.0558 / ea | $5.58 | 2023-08-22 | — | Active |
| 16571-0115-10 16571-115-10 | 1000 TABLET, FILM COATED in 1 BOTTLE | $0.0558 / ea | $55.75 | 2023-08-22 | — | Active |
| 16571-0115-50 You're viewing this Main listing | 500 TABLET, FILM COATED in 1 BOTTLE | $0.0558 / ea | $27.88 | 2023-08-22 | — | Active |
You're viewing one of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0558 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 64% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 16571-0115-01?
What NDC number is used to bill for this package of Hydroxyzine Hydrochloride 50 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxyzine Hydrochloride 50 mg 00093-5062-01 | Teva | 100 tablets | $0.056 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 00904-6618-61 | Major | 1 tablet | $0.056 | AB | Discontinued | — |
| Hydroxyzine hydrochloride 50 mg 00904-7379-40 | Major | 500 tablets | $0.056 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mgthis 16571-0115-50 | Rising | 500 tablets | $0.056 | AB | Availability likely | — |
| HydrOXYzine Hydrochloride 50 mg 16714-0083-10 | Northstar | 100 tablets | $0.056 | AB | Availability likely | — |
| Hydroxyzine hydrochloride 50 mg 23155-0502-01 | Heritage | 100 tablets | $0.056 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 24658-0783-10 | PURACAP | 1000 tablets | $0.056 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 59651-0501-01 | Aurobindo | 100 tablets | $0.056 | — | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 60687-0875-01 | American | 1 tablet | $0.056 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 62135-0575-05 | Chartwell | 500 tablets | $0.056 | AB | Availability likely | — |
| Hydroxyzine Hydrochloride 50 mg 42806-0161-01 | Epic | 100 tablets | $0.058 | AB | Availability likely | +5% |
| Hydroxyzine Hydrochloride 50 mg 10702-0012-01 | KVK-Tech, | 100 tablets | $0.068 | AB | FDA listed | +23% |
| Hydroxyzine hydrochloride 50 mg 00615-8564-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 10135-0812-01 | Marlex | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 11534-0206-01 | Sunrise | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 31722-0502-01 | Camber | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 43063-0519-30 | PD-Rx | 30 tablets | — | — | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 43063-0779-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 43063-0963-01 | PD-Rx | 100 tablets | — | — | FDA listed | — |
| HydrOXYzine Hydrochloride 50 mg 50090-2614-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 50090-6293-01 | A-S | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 51407-0971-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 51655-0119-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 51655-0467-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 62135-0547-05 | Chartwell | 500 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 63187-0354-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 63629-4929-01 | Bryant | 120 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 65162-0577-10 | Amneal | 100 tablets | — | — | FDA listed | — |
| HydrOXYzine Hydrochloride 50 mg 67296-2224-01 | Redpharm | 10 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 68071-5133-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 68071-5291-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 70518-1265-01 | REMEDYREPACK | 60 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 70518-4170-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71205-0083-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71205-0332-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71335-0246-01 | Bryant | 120 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71335-2185-01 | Bryant | 120 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71335-2410-01 | Bryant | 120 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 71335-3036-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 72162-2167-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 72162-2513-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Hydroxyzine HCL 50 mg 72189-0577-60 | Direct_rx | 60 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 72789-0269-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 72789-0378-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 76420-0883-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Hydroxyzine HCL 50 mg 80425-0173-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 80425-0376-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg 80425-0394-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 87441-0039-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Hydroxyzine hydrochloride 50 mg 70518-0487-01 | REMEDYREPACK | 90 tablets | — | AB | Discontinued | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 0VUT3PMY82
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
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UNII 1IVH67816N
Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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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.
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UNII VH2XOU12IE
Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII H8AV0SQX4D
A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis.
Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies.
The physician should reassess periodically the usefulness of the drug for the individual patient.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.
⛔ Contraindications ▾
CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range.
Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.
⚠️ Warnings ▾
WARNINGS Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic : Dry mouth. Central Nervous System : Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose.
Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System : QT prolongation, Torsade de Pointes.
In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole : Allergic reaction. Nervous System : Headache. Psychiatric : Hallucination.
Skin and Appendages : Oral hydroxyzine is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports; pruritus, rash, urticaria.
🧓 Geriatric Use ▾
Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.
🆘 Overdosage ▾
OVERDOSAGE The most common manifestation of hydroxyzine overdosage is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.
Hypotension, though unlikely, may be controlled with intravenous fluids and levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts its pressor action. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes.
ECG monitoring is recommended in cases of hydroxyzine overdose. There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine.
However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines. Hydroxyzine is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally.
Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity.
Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine's clinical effects are usually noted within 15 to 30 minutes after oral administration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydroxyzine Hydrochloride Tablets USP, 10 mg are available as round, film-coated, white tablets, debossed with "5" on one side and plain on the other side, containing 10 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 16571-113-01) and 500 (NDC 16571-113-50) tablets. Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as round, film-coated, white tablets, debossed with "50" on one side and plain on the other side, containing 25 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 16571-114-01), 500 (NDC 16571-114-50) and 1,000 (NDC 16571-114-10) tablets.
Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as round, film-coated, white tablets, debossed with "49" on one side and plain on the other side, containing 50 mg hydroxyzine hydrochloride, USP packaged in bottles of 100 (NDC 16571-115-01), 500 (NDC 16571-115-50) and 1,000 (NDC 16571-115-10) tablets. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Graviti Pharmaceuticals Pvt Ltd Telangana-502307, INDIA Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Mfg.
Lic. No.: 12/SRD/TS/2017/F/G. Revised: 06/2024
📋 Description ▾
DESCRIPTION Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 . 2HCl M.W.
447.83 Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose anhydrous, sodium starch glycolate, magnesium stearate, and purified water.
Instacoat aqua III white inactive ingredients include: hypromellose, polydextrose, triacetin, polyethylene glycol, and titanium dioxide. Meets USP Dissolution Test-3. structural formula
⚠️ Precautions ▾
PRECAUTIONS THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced. QT Prolongation/Torsade de Pointes (TdP): Cases of QT prolongation and Torsade de Pointes have been reported during post-marketing use of hydroxyzine.
The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.
Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).
Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine. Patients should also be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effects of alcohol may be increased. Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. The extent of renal excretion of hydroxyzine has not been determined.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely. Acute Generalized Exanthematous Pustulosis (AGEP) Hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema.
Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any other sign of hypersensitivity. If signs or symptoms suggest AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 16571-113-01 Rising Pharma Holdings, Inc. hydrOXYzine Hydrochloride Tablets, USP 10 mg Rx Only 100 Tablets image
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 16571-114-01 Rising Pharma Holdings, Inc. hydrOXYzine Hydrochloride Tablets, USP 25 mg Rx Only 100 Tablets image
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 16571-115-01 Rising Pharma Holdings, Inc. hydrOXYzine Hydrochloride Tablets, USP 50 mg Rx Only 100 Tablets image