Cyproheptadine Hydrochloride 4 mg Tablet, 100-count
Other active recalls for Cyproheptadine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Other antihistamines for systemic use class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Cyproheptadine is used to treat allergy symptoms: runny nose sneezing tching of the nose or throat red, itchy, or watery eyes It may also be used to relieve the itching of allergic skin conditions and to treat hives. Cyproheptadine is also used to treat severe or life-threatening allergic reactions. Cyproheptadine 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.
Read the full MedlinePlus article ↗- Cyproheptadine is an antihistamine used mainly for allergies. It can help with nasal allergy symptoms like a runny nose and sneezing, itchy or watery eyes, and skin reactions like...
- What is cyproheptadine actually used for?
- Yes — drowsiness is the most common side effect and is expected, especially when you first start taking it. For many people it eases up after a few days. That said, you should avoi...
- Is it normal to feel really tired after taking this?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.068 | $6.76 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2636 | $26.36 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2730 | $27.30 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cyproheptadine Hydrochloride 4 mg 00115-1757-01 | Amneal | 100 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mgthis 16571-0805-01 | Rising | 100 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 50268-0201-15 | AvPAK | 50 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 50742-0190-01 | Ingenus | 100 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 52817-0210-10 | TRUPHARMA, | 100 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 62135-0236-90 | Chartwell | 90 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 64380-0795-06 | Strides | 100 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 70710-1110-00 | Zydus | 1000 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 70752-0107-10 | QUAGEN | 100 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 76385-0130-01 | UNICHEM | 100 tablets | $0.068 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 4 mg 42708-0177-21 | QPharma | 21 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 42708-0187-21 | QPharma | 21 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 50090-5491-01 | A-S | 30 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 50090-6129-01 | A-S | 30 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 51407-0272-10 | Golden | 1000 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 70518-3517-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 70518-4667-00 | REMEDYREPACK | 50 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 70771-1076-00 | Zydus | 1000 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 71335-1107-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 71335-2368-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 71335-2453-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 71335-2964-01 | Bryant | 90 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 72162-2066-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 72789-0102-01 | PD-Rx | 100 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 52817-0415-10 | TRUPHARMA, | 100 tablets | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 4 mg 71335-0211-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 16571-0805-01 You're viewing this | 100 TABLET in 1 BOTTLE (16571-805-01) | $0.0676 / ea | $6.76 | 2022-02-10 | Active |
| 16571-0805-10 | 1000 TABLET in 1 BOTTLE (16571-805-10) | $0.0676 / ea | $67.62 | 2022-02-10 | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0676 NADAC).
Pack size FAQ
What quantity is in NDC 16571-0805-01?
What is the difference between NDC 16571-0805-01 and NDC 16571-0805-10?
What NDC number is used to bill for this package of Cyproheptadine Hydrochloride 4 mg Tablet?
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
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Each tablet contains 4 mg of cyproheptadine hydrochloride. Pediatric Patients Age 2 to 6 years The total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m 2 ).
The usual dose is 2 mg (½ tablet) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 12 mg a day. Age 7 to 14 years The usual dose is 4 mg (1 tablet) two or three times a day adjusted as necessary to the size and response of the patient.
The dose is not to exceed 16 mg a day. Adults The total daily dose for adults should not exceed 0.5 mg/kg/day. The therapeutic range is 4 to 20 mg a day, with the majority of patients requiring 12 to 16 mg a day.
An occasional patient may require as much as 32 mg a day for adequate relief. It is suggested that dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the size and response of the patient.
⛔ Contraindications ▾
CONTRAINDICATIONS Newborn or Premature Infants This drug should not be used in newborn or premature infants. Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Other Conditions Hypersensitivity to cyproheptadine and other drugs of similar chemical structure.
Monoamine oxidase inhibitor therapy (See DRUG INTERACTIONS .) Angle-closure glaucoma Stenosing peptic ulcer Symptomatic prostatic hypertrophy Bladder neck obstruction Pyloroduodenal obstruction Elderly, debilitated patients
⚠️ Warnings ▾
WARNINGS Pediatric Patients Overdosage of antihistamines, particularly in infants and young children, may produce hallucinations, central nervous system depression, convulsions, respiratory and cardiac arrest, and death. Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation. CNS Depressants Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.
Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients (see PRECAUTIONS, Geriatric Use ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions which have been reported with the use of antihistamines are as follows: Central Nervous System Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness. Integumentary Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity. Special Senses Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus.
Cardiovascular Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock. Hematologic Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia. Digestive System Cholestasis, hepatic failure, hepatitis, hepatic function abnormality, dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice.
Genitourinary Urinary frequency, difficult urination, urinary retention, early menses. Respiratory Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Miscellaneous Fatigue, chills, headache, increased appetite/weight gain.
To report SUSPECTED ADVERESE REACTIONS , contact Rising Pharma Holdings, Inc. at 1-844-874-7464, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation especially in pediatric patients. Also, atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing, etc.) as well as gastrointestinal symptoms may occur. If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac.
If patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic or ½ isotonic saline is the lavage of choice. Precautions against aspiration must be taken especially in infants and children.
When life threatening CNS signs and symptoms are present, intravenous physostigmine salicylate may be considered. Dosage and frequency of administration are dependent on age, clinical response, and recurrence after response. (See package circulars for physostigmine products.) Saline cathartics, as milk of magnesia, by osmosis draw water into the bowel and, therefore, are valuable for their action in rapid dilution of bowel content.
Stimulants should not be used. Vasopressors may be used to treat hypotension. The oral LD 50 of cyproheptadine is 123 mg/kg, and 295 mg/kg in the mouse and rat, respectively
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Cyproheptadine is a serotonin and histamine antagonist with anticholinergic and sedative effects. Antiserotonin and antihistamine drugs appear to compete with serotonin and histamine, respectively, for receptor sites. Pharmacokinetics and Metabolism After a single 4 mg oral dose of 14C-labelled cyproheptadine HCl in normal subjects, given as tablets, 2 to 20% of the radioactivity was excreted in the stools.
Only about 34% of the stool radioactivity was unchanged drug, corresponding to less than 5.7% of the dose. At least 40% of the administered radioactivity was excreted in the urine. No detectable amounts of unchanged drug were present in the urine of patients on chronic 12 to 20 mg daily doses.
The principle metabolite found in human urine has been identified as a quaternary ammonium glucuronide conjugate of cyproheptadine. Elimination is diminished in renal insufficiency.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off-white round convex tablets, engraved IT above bisect and 68 below bisect on one side with other side is plain, containing 4 mg of cyproheptadine HCl packaged in bottles of 100 (NDC 16571-805-01) and 1000 (NDC 16571-805-10) tablets. PHARMACIST: Dispense in a well-closed 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].
Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Rev. 08/2021
📋 Description ▾
DESCRIPTION Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5 H -dibenzo [a,d] cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride.
The molecular formula of the anhydrous salt is C 21 H 21 N•HCl and the structural formula of the anhydrous salt is: C 21 H 21 N• HCl M.W. 350.89 Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. structure.jpg