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Clemastine Fumarate .67 mg/5mL Syrup, 120 mL — NDC 64950-0324-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clemastine Fumarate .67 mg/5mL Syrup, 120 mL — NDC 64950-324-12 (Billing 64950-0324-12)

by Genus Lifesciences · 120 mL in 1 BOTTLE

This is a package of 120 mL of Clemastine Fumarate .67 mg/5mL Syrup from Genus Lifesciences, marketed since Nov 2024 and currently FDA-listed; retail pharmacies pay about $5.49 per mL (NADAC). It is this product's only package size.

NDC 64950-0324-12
🏷️ FDA NDC (as labeled) 64950-324-12 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64950-324-12
Product NDC 64950-324
11-digit billing NDC 64950032412
NCPDP billing unit ML — per mL (volume)
RxCUI 857430
UNII 19259EGQ3D
Application # ANDA073399
SPL Set ID 5c99e7af-86a5-4c17-82d5-2d4119e4fe72
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-22
Route ORAL
Dosage form SYRUP
Substance CLEMASTINE FUMARATE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 41200020401205
GCN Seq No 011654
GCN 46990
HICL code 004512
Ingredient (HICL) Clemastine Fumarate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name CLEMASTINE 0.5 MG/5 ML SYRUP
FDB brand name Clemastine Fumarate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 011654
  • GCN: 46990
  • GPI-14 (Medi-Span): 41200020401205
  • HICL (First Databank): 004512
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 857430
Why two NDCs? The FDA registers this code as 64950-324-12 — 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 → 64950-0324-12. 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 Antihistamines for topical use class.

Drug family (ATC) Antihistamines for topical use, Aminoalkyl ethers
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.

Clinical

Label name CLEMASTINE 0.5 MG/5 ML SYRUP Ingredient Clemastine Fumarate
📖 What it is MedlinePlus · NLM

Clemastine is used to treat allergy symptoms: runny nose sneezing itching of the nose or throat red, itchy, or watery eyes Clemastine is also used to relieve the itching and swelling of hives. Clemastine 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 ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves allergy symptoms like sneezing, runny nose, itching and watery eyes. It is also used for mild allergic skin reactions such as hives and angioedema, at the higher dosage...
  • Quite possibly. Drowsiness is the most common side effect. Wait to see how it affects you before driving or using machinery, and avoid alcohol and other sedating medicines because...
  • You take it by mouth, as a syrup or tablet. The syrup is generally taken twice daily, and the tablets up to three times daily at most. Your prescriber will tailor the dose, so foll...
  • If you are breastfeeding, no. The label says antihistamines are contraindicated for nursing mothers because of higher risk to infants. For pregnancy, there is not enough experience...
📖 Read our full Clemastine guide →
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.

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 $5.492 $659.00 / 120 ml
Medicaid paysCMS SDUD · 12 mo $13.54 $1,625.36 / 120 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $5.522 $5.416
▼ Down 1% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
64950-0324-12 You're viewing this Main listing 120 mL in 1 BOTTLE 2024-11-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clemastine Fumarate .67 mg/5mLthis 64950-0324-12 Genus 120 ml $5.492 AA Availability likely —
Clemastine Fumarate .67 mg/5mL 62135-0713-41 Chartwell 120 ml — 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

🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

FlavorCitrus
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 91XW058U2C
    Maleic acid is an organic acid derived from maleic anhydride. In medicines, it acts as a buffer to help maintain the proper pH level and may also serve as a preservative or stabilizing agent in the formulation.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

9 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 DailyMed — 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

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.

Manufacturer & labeler

LabelerGenus Lifesciences
Application holderGENUS LIFESCIENCES INC
FDA applicationANDA073399 (ANDA)
Labeler code64950
First marketedNov 2024
Product typeHuman Prescription Drug
Portfolio25 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.

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 74 words ▾

INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION ). It should be noted that clemastine is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.

⏱️ Dosage and Administration 158 words ▾

DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. Pediatric Children aged 6 to 12 years For Symptoms of Allergic Rhinitis The starting dose is 1 teaspoonful (0.5 mg clemastine) twice daily. Since single doses of up to 2.25 mg clemastine were well tolerated by this age group, dosage may be increased as required, but not to exceed 6 teaspoonfuls daily (3 mg clemastine).

For Urticaria and Angioedema The starting dose is 2 teaspoonfuls (1 mg clemastine) twice daily, not to exceed 6 teaspoonfuls daily (3 mg clemastine). Adults and Children 12 Years and Over For Symptoms of Allergic Rhinitis The starting dose is 2 teaspoonfuls (1 mg clemastine) twice daily. Dosage may be increased as required, but not to exceed 12 teaspoonfuls daily (6 mg clemastine).

For Urticaria and Angioedema The starting dose is 4 teaspoonfuls (2 mg clemastine) twice daily, not to exceed 12 teaspoonfuls daily (6 mg clemastine).

⛔ Contraindications 62 words ▾

CONTRAINDICATIONS Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure (see PRECAUTIONS- Drug Interactions ). Antihistamines should not be used in newborn or premature infants . Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers (see PRECAUTIONS-Nursing Mothers ).

⚠️ Warnings 93 words ▾

WARNINGS Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. Use with CNS Depressants Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.). Use in Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Use in the Elderly (approximately 60 years or older) Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

🤒 Adverse Reactions 118 words ▾

ADVERSE REACTIONS The most frequent adverse reactions are italicized: Nervous System Sedation , sleepiness , dizziness , disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal System Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness.

Cardiovascular System Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System Hemolytic anemia, thrombocytopenia, agranulocytosis. Genitourinary System Urinary frequency, difficult urination, urinary retention, early menses.

General Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat. To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 48 words ▾

Drug Interactions Additive CNS depression may occur when antihistamines are administered concomitantly with other CNS depressants including barbiturates, tranquilizers, and alcohol. Patients receiving antihistamines should be advised against the concurrent use of other CNS depressant drugs. Monoamine oxidase (MAO) inhibitors prolong and intensify the anticholinergic effects of antihistamines.

🤰 Pregnancy 72 words ▾

Pregnancy Teratogenic Effects Pregnancy Category B Oral reproduction studies performed with clemastine fumarate in rats and rabbits at doses up to 312 and 188 times the adult human doses respectively, have revealed no evidence of teratogenic effects. There are no adequate and well-controlled studies of clemastine fumarate in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.

🧒 Pediatric Use 88 words ▾

Pediatric Use The safety and efficacy of Clemastine Fumarate Syrup has been confirmed in the pediatric population (age 6 years through 12). Safety and dose tolerance studies have confirmed pediatric patients 6 through 11 years tolerated dosage ranges of 0.75 to 2.25 mg clemastine. In pediatric patients particularly, antihistamines in overdosage may produce hallucinations, convulsions and death.

Symptoms of antihistamine toxicity in pediatric patients may include fixed dilated pupils, flushed face, dry mouth, fever, excitation, hallucinations, ataxia, incoordination, athetosis, tonic- lonic convulsions, and postictal depression (see OVERDOSAGE ).

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. In children, stimulation predominates initially in a syndrome which may include excitement, hallucinations, ataxia, incoordination, muscle twitching, athetosis, hyperthermia, cyanosis convulsions, tremors, and hyperreflexia followed by postictal depression and cardio-respiratory arrest. Convulsions in children may be preceded by mild depression.

Dry mouth, fixed dilated pupils, flushing of the face, and fever are common. In adults, CNS depression, ranging from drowsiness to coma, is more common. The convulsant dose of antihistamines lies near the lethal dose.

Convulsions indicate a poor prognosis. In both children and adults, coma and cardiovascular collapse may occur. Deaths are reported especially in infants and children.

There is no specific therapy for acute overdosage with antihistamines. The latent period from ingestion to appearance of toxic effects is characteristically short (1/2-2 hours). General symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary.

Since overdoses of other classes of drugs (i.e. tricyclic antidepressants) may also present anticholinergic symptomatology, appropriate toxicological analysis should be performed as soon as possible to identify the causative agent. In the conscious patient, vomiting should be induced even though it may have occurred spontaneously. If vomiting cannot be induced, gastric lavage is indicated.

Adequate precautions must be taken to protect against aspiration, especially in infants and children. Charcoal slurry or other suitable agents should be instilled into the stomach after vomiting or lavage. Saline cathartics or milk of magnesia may be of additional benefit.

In the unconscious patient, the airway should be secured with a cuffed endotracheal tube before attempting to evacuate the gastric contents. Intensive supportive and nursing care is indicated, as for any comatose patient. If breathing is significantly impaired, maintenance of an adequate airway and mechanical support of respiration is the most effective means of providing adequate oxygenation.

Hypotension is an early sign of impending cardiovascular collapse and should be treated vigorously. Although general supportive measures are important, specific treatment with intravenous infusion of a vasopressor titrated to maintain adequate blood pressure may be necessary. Do not use with CNS stimulants.

Convulsions should be controlled by careful administration of diazepam or a short-acting barbiturate, repeated as necessary. Physostigmine may also be considered for use in controlling centrally mediated convulsions. Ice packs and cooling sponge baths, not alcohol, can aid in reducing the fever commonly seen in children.

A more detailed review of antihistamine toxicology and overdose management is available in Gosselin, R.E., et. al., "Clinical Toxicology of Commercial Products."

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines competitively antagonize various physiological effects of histamine including increased capillary permeability and dilatation, the formation of edema, the "flare" and "itch" response, and gastrointestinal and respiratory smooth muscle constriction. Within the vascular tree, H1-receptor antagonists inhibit both the vasoconstrictor and vasodilator effects of histamine.

Depending on the dose, H1-receptor antagonists can produce CNS stimulation or depression. Most antihistamines exhibit central and/or peripheral anticholinergic activity. Antihistamines act by competitively blocking H1-receptor sites.

Antihistamines do not pharmacologically antagonize or chemically inactivate histamine, nor do they prevent the release of histamine. Pharmacokinetics Antihistamines are well-absorbed following oral administration. Chlorpheniramine maleate, clemastine fumarate, and diphenhydramine hydrochloride achieve peak blood levels within 2-5 hours following oral administration.

The absorption of antihistamines is often partially delayed by the use of controlled release dosage forms. In these instances, plasma concentrations from identical doses of the immediate and controlled release dosage forms will not be similar. Tissue distribution of the antihistamines in humans has not been established.

Antihistamines appear to be metabolized in the liver chiefly via mono- and didemethylation and glucuronide conjugation. Antihistamine metabolites and small amounts of unchanged drug are excreted in the urine. Small amounts of the drugs may also be excreted in breast milk.

In normal human subjects who received histamine injections over a 24-hour period, the antihistaminic activity of clemastine reached a peak at 5-7 hours, persisted for 10-12 hours and, in some cases, for as long as 24 hours. Pharmacokinetic studies in man utilizing 3H and 14C labeled compound demonstrates that: clemastine is rapidly absorbed from the gastrointestinal tract, peak plasma concentrations are attained in 2-4 hours, and urinary excretion is the major mode of elimination.

📦 How Supplied / Storage and Handling 49 words ▾

HOW SUPPLIED Clemastine Fumarate Syrup: clemastine 0.5 mg/5 mL (present as clemastine fumarate 0.67 mg/5 mL). A clear, colorless liquid with a citrus flavor (passion fruit), in 120 mL bottle. 120 mL bottle (NDC 64950-324-12) Store at controlled room temperature, between 20° and 25°C (68° and 77°F) (see USP).

📦 Storage and Handling 14 words ▾

Store at controlled room temperature, between 20° and 25°C (68° and 77°F) (see USP).

📋 Description 99 words ▾

DESCRIPTION Each 5 mL (teaspoonful) of Clemastine Fumarate Syrup for oral administration contains clemastine 0.5 mg (present as clemastine fumarate 0.67 mg). Other ingredients: Alcohol 5.5%, Flavors, Maleic Acid, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sodium Hydroxide, and Sorbitol. Clemastine fumarate belongs to the benzhydryl ether group of antihistaminic compounds.

The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate and has the following structural formula: C 21 H 26 ClNO∙C 4 H 4 O 4 M.W. 459.97 Clemastine fumarate occurs as a colorless to faintly yellow, odorless, crystalline powder. Clemastine Fumarate Syrup has an approximate pH of 6.2.

Chemical Structure

💬 Information for Patients 122 words ▾

Information for Patients Patients taking antihistamines should receive the following information and instructions: Antihistamines are prescribed to reduce allergic symptoms. Patients should be questioned regarding a history of glaucoma, peptic ulcer, urinary retention, or pregnancy before starting antihistamine therapy. Patients should be told not to take alcohol, sleeping pills, sedatives, or tranquilizers while taking antihistamines.

Antihistamines may cause drowsiness, dizziness, dry mouth, blurred vision, weakness, nausea, headache, or nervousness in some patients. Patients should avoid driving a car or working with hazardous machinery until they assess the effects of this medicine. Patients should be told to store this medicine in a tightly closed container in a dry, cool place away from heat or direct sunlight and out of the reach of children.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Clemastine fumarate should be used with caution in patients with: history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypertension. Information for Patients Patients taking antihistamines should receive the following information and instructions: Antihistamines are prescribed to reduce allergic symptoms. Patients should be questioned regarding a history of glaucoma, peptic ulcer, urinary retention, or pregnancy before starting antihistamine therapy.

Patients should be told not to take alcohol, sleeping pills, sedatives, or tranquilizers while taking antihistamines. Antihistamines may cause drowsiness, dizziness, dry mouth, blurred vision, weakness, nausea, headache, or nervousness in some patients. Patients should avoid driving a car or working with hazardous machinery until they assess the effects of this medicine.

Patients should be told to store this medicine in a tightly closed container in a dry, cool place away from heat or direct sunlight and out of the reach of children. Drug Interactions Additive CNS depression may occur when antihistamines are administered concomitantly with other CNS depressants including barbiturates, tranquilizers, and alcohol. Patients receiving antihistamines should be advised against the concurrent use of other CNS depressant drugs.

Monoamine oxidase (MAO) inhibitors prolong and intensify the anticholinergic effects of antihistamines. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis In a 2-year oral study in the rat at a dose of 84 mg/kg (about 500 times the adult human dose) and an 85-week oral study in the mouse at 206 mg/kg (about 1300 times the adult human dose), clemastine fumarate showed no evidence of carcinogenesis. No mutagenic studies have been conducted with clemastine fumarate.

Impairment of Fertility Oral doses of clemastine fumarate in the rat produced a decrease in mating ability of the male at 312 times the adult human dose. This effect was not found at 156 times the adult human dose. Pregnancy Teratogenic Effects Pregnancy Category B Oral reproduction studies performed with clemastine fumarate in rats and rabbits at doses up to 312 and 188 times the adult human doses respectively, have revealed no evidence of teratogenic effects.

There are no adequate and well-controlled studies of clemastine fumarate in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Nursing Mothers Although quantitative determinations of antihistaminic drugs in breast milk have not been reported, qualitative tests have documented the excretion of diphenhydramine, pyrilamine, and tripelennamine in human milk.

Because of the potential for adverse reactions in nursing infants from antihistamines, a decision should be made whether to discontinue nursing or to discontinue the drug. Pediatric Use The safety and efficacy of Clemastine Fumarate Syrup has been confirmed in the pediatric population (age 6 years through 12). Safety and dose tolerance studies have confirmed pediatric patients 6 through 11 years tolerated dosage ranges of 0.75 to 2.25 mg clemastine.

In pediatric patients particularly, antihistamines in overdosage may produce hallucinations, convulsions and death. Symptoms of antihistamine toxicity in pediatric patients may include fixed dilated pupils, flushed face, dry mouth, fever, excitation, hallucinations, ataxia, incoordination, athetosis, tonic- lonic convulsions, and postictal depression (see OVERDOSAGE ).

🍼 Nursing Mothers 55 words ▾

Nursing Mothers Although quantitative determinations of antihistaminic drugs in breast milk have not been reported, qualitative tests have documented the excretion of diphenhydramine, pyrilamine, and tripelennamine in human milk. Because of the potential for adverse reactions in nursing infants from antihistamines, a decision should be made whether to discontinue nursing or to discontinue the drug.

🧬 Pharmacokinetics 186 words ▾

Pharmacokinetics Antihistamines are well-absorbed following oral administration. Chlorpheniramine maleate, clemastine fumarate, and diphenhydramine hydrochloride achieve peak blood levels within 2-5 hours following oral administration. The absorption of antihistamines is often partially delayed by the use of controlled release dosage forms.

In these instances, plasma concentrations from identical doses of the immediate and controlled release dosage forms will not be similar. Tissue distribution of the antihistamines in humans has not been established. Antihistamines appear to be metabolized in the liver chiefly via mono- and didemethylation and glucuronide conjugation.

Antihistamine metabolites and small amounts of unchanged drug are excreted in the urine. Small amounts of the drugs may also be excreted in breast milk. In normal human subjects who received histamine injections over a 24-hour period, the antihistaminic activity of clemastine reached a peak at 5-7 hours, persisted for 10-12 hours and, in some cases, for as long as 24 hours.

Pharmacokinetic studies in man utilizing 3H and 14C labeled compound demonstrates that: clemastine is rapidly absorbed from the gastrointestinal tract, peak plasma concentrations are attained in 2-4 hours, and urinary excretion is the major mode of elimination.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 102 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis In a 2-year oral study in the rat at a dose of 84 mg/kg (about 500 times the adult human dose) and an 85-week oral study in the mouse at 206 mg/kg (about 1300 times the adult human dose), clemastine fumarate showed no evidence of carcinogenesis. No mutagenic studies have been conducted with clemastine fumarate. Impairment of Fertility Oral doses of clemastine fumarate in the rat produced a decrease in mating ability of the male at 312 times the adult human dose.

This effect was not found at 156 times the adult human dose.

📄 Package Label / Principal Display Panel 47 words ▾

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label NDC 64950-324-12 Clemastine Fumarate Syrup 0.5 mg/5 mL* Each 5 mL (teaspoonful) contains: Clemastine 0.5 mg* Alcohol 5.5% *(present as clemastine fumarate 0.67 mg) Rx only 120 mL Genus Lifesciences Inc. PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
2.6K
Units reimbursed last 4 qtrs
703.2K
Gross reimbursed last 4 qtrs
$9.52M
Avg / prescription
$3,677.54
Avg / unit
$13.5447
Latest quarter Q1 2026
167Rx
Medicaid pays / mL
$13.5447
gross reimbursed
vs
NADAC / mL
$5.4917
acquisition cost
=
Spread
+$8.0530
+147% 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 ⓘ
17% FFS 83% MCO
Fee-for-service · 434 Rx Managed care · 2,156 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 146,100 units · 1,456 per 100k residents MI New York: 34,020 units · 174 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 238,194 units · 7,458 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 27,600 units · 234 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 170,000 units · 1,830 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 12,840 units · 284 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 74,460 units · 1,458 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1747,458
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 Nevada 7,458 /100k
2 New Jersey 1,830 /100k
3 Alabama 1,458 /100k
4 Michigan 1,456 /100k
5 Kentucky 284 /100k
6 Ohio 234 /100k
7 New York 174 /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 Clemastine Fumarate — the program that covers self-administered drugs. 2 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 Clemastine Fumarate. 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
$6.17M
Claims incl. refills
1.9K
Beneficiaries
982
Spend / beneficiary
$6,287.79
Spend / claim
$3,330.43
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.
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.