Pyrantel Pamoate

Manufacturer
Neogen Corporation dba Columbia Laboratories | Neogen Corporation - Mercer Rd. | minsheng group shaoxing pharmaceutical co. ltd
Effective date
2024-08-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:16:51

Label at a glance#

ProductPyrantel Pamoate
Active ingredientPYRANTEL PAMOATE
Label structure14 sections

Dosage and administration

Shake well before use. Adults, children 12 years of age and over, and children 2 years to under 12 years of age - oral dosage is a single dose of 5 milligrams of Pyrantel Base per pound (or 11 milligrams per kilogram) of body weight, not to exceed 1 gram (4 teaspoonfuls). WEIGHT DOSAGE(TAKEN AS A SINGLE DOSE) Less than 25 Pounds or under 2 years old Do not us unless directed by a physician 25 to 37 Pounds ½ teaspo...

Storage and handling

Recommended storage: Store at temperature between 15°C - 30°C (59°F - 86°F).

Label contents#

Full prescribing information#

Active Ingredients (in each 1 tsp)

OTC - ACTIVE INGREDIENT SECTION

Pyrantel base: 250 mg

(as Pyrantel Pamoate)

Purpose

OTC - PURPOSE SECTION

Pinworm treatment

Indication

INDICATIONS & USAGE SECTION

For the treatment of pinworms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or have liver disease,do not take this product unless directed by a physician.

OTC - WHEN USING SECTION

When using this product,abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist, consult a physician. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use.
  • Adults, children 12 years of age and over, and children 2 years to under 12 years of age - oral dosage is a single dose of 5 milligrams of Pyrantel Base per pound (or 11 milligrams per kilogram) of body weight, not to exceed 1 gram (4 teaspoonfuls).
WEIGHTDOSAGE(TAKEN AS A SINGLE DOSE)
Less than 25 Pounds or under 2 years oldDo not us unless directed by a physician
25 to 37 Pounds½ teaspoonful (125 mg)
38 to 62 Pounds1 teaspoonful (250 mg)
63 to 87 Pounds1½ teaspoonfuls (375 mg)
88 to 112 Pounds2 teaspoonfuls (500 mg)
113 to 137 Pounds2½ teaspoonfuls (625 mg)
138 to 162 Pounds3 teaspoonfuls (750 mg)
163 to 187 Pounds3½ teaspoonfuls (875 mg)
188 Pounds and over4 teaspoonfuls (1000 mg)
  • Dosage information: Each 5 mL (1 teaspoonful) of Pyrantel Pamoate Suspension contains the equivalent of 250 mg of Pyrantel Base.
  • Read package insert carefully before taking this medication.
  • Take only according to directions and do not exceed the recommended dosage unless directed by a physician.
  • Medication should only be taken one time as a single dose, do not repeat treatment - unless directed by a physician.
  • When one individual in a household has pinworms, the entire household should be treated unless otherwise advised.
  • If any worms other than pinworms are present before or after treatment, consult a physician.
  • If any symptoms or pinworms are still present after treatment, consult a physician.
  • This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice.
  • Use of a laxative is not necessary prior to, during, or after medication.

Other information

STORAGE AND HANDLING SECTION

  • Recommended storage: Store at temperature between 15°C - 30°C (59°F - 86°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Potassium Sorbate, Purified Water, USP, Sodium Benzoate, Sucrose, Vanilla Flavor, and Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

For 24-hour emergency information on this product, call 1-800-498-5743.

USER SAFETY WARNINGS SECTION

DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

PYRANTEL PAMOATE ORAL SUSPENSION USP (Pyrantel base: 50 mg / mL) PINWORM TREATMENT

SPL PATIENT PACKAGE INSERT SECTION

Drug Facts

Active ingredient

(in each 1 tsp)

Pyrantel base: 250 mg

(as Pyrantel Pamoate)

Purpose

Pinworm treatment

Indication For the treatment of pinworms.

Warnings

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately.

If you are pregnant or have liver disease,do not take this product unless directed by a physician.

When using this product,abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist, consult a physician.

Directions

  • Shake well before use.
  • Adults, children 12 years of age and over, and children 2 years to under 12 years of age - oral dosage is a single dose of 5 milligrams of Pyrantel Base per pound (or 11 milligrams per kilogram) of body weight, not to exceed 1 gram (4 teaspoonfuls).
WEIGHTDOSAGE (TAKEN AS A SINGLE DOSE)
Less than 25 Pounds or under 2 years oldDo not us unless directed by a physician
25 to 37 Pounds½ teaspoonful (125 mg)
38 to 62 Pounds1 teaspoonful (250 mg)
63 to 87 Pounds1½ teaspoonfuls (375 mg)
88 to 112 Pounds2 teaspoonfuls (500 mg)
113 to 137 Pounds2½ teaspoonfuls (625 mg)
138 to 162 Pounds3 teaspoonfuls (750 mg)
163 to 187 Pounds3½ teaspoonfuls (875 mg)
188 Pounds and over4 teaspoonfuls (1000 mg)
  • Dosage information: Each 5 mL (1 teaspoonful) of Pyrantel Pamoate Suspension contains the equivalent of 250 mg of Pyrantel Base.
  • Read package insert carefully before taking this medication.
  • Take only according to directions and do not exceed the recommended dosage unless directed by a physician.
  • Medication should only be taken one time as a single dose, do not repeat treatment - unless directed by a physician.
  • When one individual in a household has pinworms, the entire household should be treated unless otherwise advised.
  • If any worms other than pinworms are present before or after treatment, consult a physician.
  • If any symptoms or pinworms are still present after treatment, consult a physician.
  • This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice.
  • Use of a laxative is not necessary prior to, during, or after medication.

Other information

  • Recommended storage: Store at temperature between 15°C - 30°C (59°F - 86°F).

Inactive Ingredients

Citric Acid, Potassium Sorbate, Purified Water, USP, Sodium Benzoate, Sucrose, Vanilla Flavor, and Xanthan Gum

Questions?Call 859-254-1221 or toll-free 800-621-8829.

PYRANTEL PAMOATE

READ THIS INSERT THOROUGHLY BEFORE TAKING THIS PRODUCT.

This brochure will tell you about pinworms and how to treat infections effectively with Pyrantel Pamoate. Many who have pinworms do not have symptoms. Nevertheless, many will experience itching in and around the rectal opening. The itching may be very annoying and continued scratching can cause an irritation in this area. The itching may be presented at night when sleeping. That is why restless sleep is sometimes a sign of pinworms, especially in children. It is important for you to realize that you should only treat with Pyrantel Pamoate if you have seen and identified the pinworms.

Pinworms look like tiny white threads. The female pinworm is about ½ long (the male pinworm is shorter). They live in the bowel. Usually, at night, the female travels to the rectal opening and lays eggs within the skin folds around the opening. This usually takes place within one to two hours after the child has been put to bed for the night. The sticky gelatin-like substance in which the eggs (they are too small to see) are deposited and the movement of the female pinworm may cause annoying itching and possibly restless sleep. By checking the rectal opening at this time, you can attempt to see the pinworm as described.

The pinworm eggs normally survive for as long as three weeks. In that time, the pinworm egg may hatch and the pinworm will travel back within the rectal opening into the bowel. The pinworm reaches maturity in the bowel within two to six weeks and the life cycle repeats itself.

Scratching will cause pinworm eggs to stick to the fingers. Reinfection will result if the fingers are placed in the mouth. The eggs, which are too small to see, contaminate whatever they come in contact with: bed clothes, underwear, toys, hands, and food touched by contaminated hands. Even eggs floating in the air can be swallowed and cause infection. Eggs deposited in the environment, as stated above, can survive for as long as three weeks. Pinworms are highly contagious. Even the cleanest and most careful people can get them.

After treatment with Pyrantel Pamoate, there are some rules to follow to try to prevent spreading to others and reinfection:

  • Wash hands and fingernails with soap often during the day, especially before eating and after using the toilet.
  • Wear tight underpants both day and night. Change them daily.
  • For several days after treatment, clean the bedroom floor by vacuuming or damp mopping. Avoid dry sweeping that may stir up dust.
  • After treatment, wash bed linens and night clothes (don't shake them).
  • Keep the toilet seats clean.

Colombia Laboratories

944 Nandino Blvd.

Lexington, KY 40511

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 62337-415-16

PYRANTEL PAMOATE SUSPENSION

(Pyrantel base: 50 mg / mL)

PINWORM TREATMENT

COLOMBIA LABORATORIES

944 Nandino Blvd.

Lexington, KY 40511

NET CONTENTS:16 FL OZ (473.2 mL)

COLUMBIA Pyrantel Pamoate Suspension - 16 fl ozCOLUMBIA Pyrantel Pamoate Suspension - 16 fl oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 62337-415-32

PYRANTEL PAMOATE SUSPENSION

(Pyrantel base: 50 mg / mL)

PINWORM TREATMENT

COLOMBIA LABORATORIES

944 Nandino Blvd.

Lexington, KY 40511

NET CONTENTS:32 FL OZ (946.4 mL)

COLUMBIA Pyrantel Pamoate Suspension - 32 fl ozCOLUMBIA Pyrantel Pamoate Suspension - 32 fl oz

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62337-415PYRANTEL PAMOATE (PINWORMTREATMENT) SUSPENSION [NEOGEN CORPORATION DBA COLUMBIA LABORATORIES]7Legacy NDC20240808_fb7cf21d-1574-4a51-ada8-c2d264297e29.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PYRANTEL PAMOATEACTIVE INGREDIENT81BK194Z5M1
PYRANTELACTIVE MOIETY4QIH0N49E71
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SUCROSEINACTIVE INGREDIENTC151H8M5541
VANILLAINACTIVE INGREDIENTQ74T35078H1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62337-41562337-415-16, 62337-415-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 251 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
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POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
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XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
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BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
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XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
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POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
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BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
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BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
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BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
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XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
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POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
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POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
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BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EFFERVESCENT / ORAL460 mgExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
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SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
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CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1f06b4a2-b84d-71ac-e063-6294a90a7f50fb7cf21d-1574-4a51-ada8-c2d264297e292024-08-06WarningsExact identifier
spl id: 1f06b4a2-b84d-71ac-e063-6294a90a7f50
spl set id: fb7cf21d-1574-4a51-ada8-c2d264297e29

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.