CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL Solution, 473 mL
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 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?
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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 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.
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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.
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UNII REK4960K2U
Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII V95R5KMY2B
Peppermint is a flavoring agent derived from the peppermint plant. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
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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.
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UNII X045WJ989B
Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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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.
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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.
10 inactive ingredients listed in the exact product block matched to this NDC.
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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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.042 | $19.91 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0633 | $29.94 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.0807 | $38.17 / 473 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| cyproheptadine hydrochloride solution 2 mg/5mL 58657-0697-16 | Method | 473 ml | $0.041 | AA | Availability likely | save 2% |
| Cyproheptadine Hydrochloride 2 mg/5mL 70752-0101-12 | QUAGEN | 473 ml | $0.041 | AA | Availability likely | save 2% |
| Cyproheptadine Hydrochloride 2 mg/5mL 39328-0544-16 | Patrin | 473 ml | $0.042 | AA | Availability likely | — |
| Cyproheptadine 2 mg/5mL 62135-0949-47 | Chartwell | 473 ml | $0.042 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 2 mg/5mL 64980-0504-48 | Rising | 473 ml | $0.042 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 2 mg/5mLthis 70752-0185-12 | QUAGEN | 473 ml | $0.042 | AA | Availability likely | — |
| Cyproheptadine Hydrochloride 2 mg/5mL 17856-0504-01 | Atlantic | 120 syringes | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 2 mg/5mL 27808-0099-01 | Tris | 473 ml | — | — | FDA listed | — |
| Cyproheptadine Hydrochloride 2 mg/5mL 72162-2065-02 | Bryant | 473 ml | — | AA | FDA listed | — |
| Cyproheptadine Hydrochloride 2 mg/5mL 17856-1185-01 | Atlantic | 72 cups | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
🔬 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 |
|---|---|---|---|
| 70752-0185-12 You're viewing this | 473 mL in 1 BOTTLE, PLASTIC (70752-185-12) | 2023-12-22 | Active |
📄 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. Although intended primarily for administration to children, the syrup is also used for administration to adults who cannot swallow tablets. Children: The total daily dosage for children may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day (0.11 mg/lb/day) or 8 mg per square meter of body surface (8 mg/m 2 ).
Age 2 to 6 years: The usual dose is 2 mg (one teaspoonful) 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 (two teaspoonsful) 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 (0.23 mg/lb/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 (two teaspoonsful) 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 Children: Overdosage of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system depression, convulsions 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.
🤒 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: 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 ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.
🔄 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: Pregnancy Category B. 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 years have not been established. (See CONTRAINDICATIONS, Newborn or Premature Infants , and WARNINGS, Children .)
🆘 Overdosage ▾
OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation especially in children. 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 the patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic or 1/2 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-labeled cyproheptadine HCI in normal subjects, given as tablets or syrup, 2-20% 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 12-20 mg daily doses of cyproheptadine syrup.
The principal 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 Oral Solution, USP, 2 mg/5 mL in a yellow, peppermint flavor vehicle, is supplied in a pint (473 mL) container (NDC 70752-101-12) & (NDC 70752-185-12)-Sugar Free Store at 20°-25°C (68°-77°F) excursion permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
📋 Description ▾
DESCRIPTION Each 5 mL (one teaspoonful) contains: Cyproheptadine Hydrochloride 2 mg Inactive Ingredients: Citric acid, D&C Yellow #10, peppermint flavor, purified water, propylene glycol, sodium citrate, sorbic acid (0.1% as preservative) and sucrose syrup. Inactive ingredients for Cyproheptadine Oral Solution (Sugar Free): alcohol 5% (v/v), butylated hydroxyanisole, citric acid, D&C Yellow #10, peppermint flavor, propylene glycol, purified water, sodium citrate, sorbic acid (0 . 1%, as preservative), sucralose.
Cyproheptadine HCl is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a white to slightly yellowish, crystalline solid, with a molecular weight of 350.89, which is slightly 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: image description