CYPROHEPTADINE HYDROCHLORIDE 4 mg Tablet, 100-count
Other active recalls for Cyproheptadine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other antihistamines for systemic use class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- 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 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 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 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2730 | $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 mg 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 mgthis 71335-2453-04 | Bryant | 100 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?
🔬 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 | Marketing start | Status |
|---|---|---|---|
| 71335-2453-01 | 30 TABLET in 1 BOTTLE (71335-2453-1) | 2024-08-20 | Active |
| 71335-2453-02 | 60 TABLET in 1 BOTTLE (71335-2453-2) | 2024-08-20 | Active |
| 71335-2453-03 | 28 TABLET in 1 BOTTLE (71335-2453-3) | 2024-08-20 | Active |
| 71335-2453-04 You're viewing this | 100 TABLET in 1 BOTTLE (71335-2453-4) | 2024-08-20 | Active |
| 71335-2453-05 | 90 TABLET in 1 BOTTLE (71335-2453-5) | 2024-08-20 | Active |
You're viewing the largest of 5 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71335-2453-04?
What is the difference between NDC 71335-2453-04 and NDC 71335-2453-03?
What NDC number is used to bill for this package of CYPROHEPTADINE HYDROCHLORIDE 4 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 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. Lactation 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
Newborn or Premature Infants This drug should not be used in newborn or premature infants.
Lactation Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.
⚠️ 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 ).
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.
🔄 Drug Interactions ▾
Drug Interactions MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.
🤰 Pregnancy ▾
Pregnancy Reproduction studies have been performed in rabbits, mice, and rats at oral or subcutaneous doses up to 32 times the maximum recommended human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyproheptadine. Cyproheptadine has been shown to be fetotoxic in rats when given by intraperitoneal injection in doses four times the maximum recommended human oral dose. Two studies in pregnant women, however, have not shown that cyproheptadine increases the risk of abnormalities when administered during the first, second and third trimesters of pregnancy.
No teratogenic effects were observed in any of the newborns. Nevertheless, because the studies in humans cannot rule out the possibility of harm, cyproheptadine should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients below the age of two have not been established (see CONTRAINDICATIONS, Newborn or Premature Infants , and WARNINGS, Pediatric Patients ).
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of cyproheptadine HCl tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently 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 (see WARNINGS, Activities Requiring Mental Alertness ).
🆘 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 14 C-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, flat-faced, beveled-edged tablets, debossed “T” above “07” below the score on one side and plain on the other side. NDC: 71335-2453-1: 30 Tablets in a BOTTLE, NDC: 71335-2453-2: 60 Tablets in a BOTTLE, NDC: 71335-2453-3: 28 Tablets in a BOTTLE, NDC: 71335-2453-4: 100 Tablets in a BOTTLE, NDC: 71335-2453-5: 90 Tablets in a BOTTLE 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]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 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-( 5H-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: 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.