FDA.reportPublic FDA data

PARASITOL

Manufacturer
Menper Distributors Inc. | RNV, LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:08:23

Label at a glance#

ProductPARASITOL
Active ingredientPYRANTEL PAMOATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

PYRANTEL PAMOATE 144 MG (equivalent to 50 mg pyrantel base)

OTC - PURPOSE SECTION

PURPOSE

Pinworm treatment

INDICATIONS & USAGE SECTION

USES

FOR THE TREATMENT OF PINWORMS.

WARNINGS SECTION

WARNINGS

Do not Exceed recommended usage

Whenm 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 doctor.

Ask a doctor before use if you have liver disease

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, seek medical attention or contact a Poison Control Center Immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless direct by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless direct by a doctor. When one individual in a household has pinworms, the entire household should be treated unless otherwise advised. See Warnings. If any worms other than pinworms are present before or after treatmen, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.

 Weight Single Dose
 Less than 25 pounds or under 2 years of age Do not use unless directed by a doctor
 25 to 37 pounds 1/2 teaspoonful (2.5 mL)
 38 to 62 pounds    1 teaspoonful (5 mL)
 63 to 87 pounds 1 1/2 teaspoonfuls (7.5 mL)
 88 to 112 pounds 2 teaspoonfuls (10 mL)
 113 to 137 pounds 2 1/2 teaspoonfuls (12.5 mL)
 138 to 162 pounds3 teaspoonfuls (15 mL) 
 163 to 187 pounds3 1/2 teaspoonfuls (17.5 mL) 
 188 pounds and over4 teaspoonfuls (20 mL) 

 Shake well before use. 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.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

acesulfame potassium, cherry flavor, citric acid, glycerin, methylparaben, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium bezoate, sodium carboximethylcellulose, sodium citrate, sorbitol, water, xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PARASITOL_Drug FactsPARASITOL_Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199106pyrantel pamoate 144 MG in 1 mL Oral SuspensionPSN4
199106pyrantel pamoate 144 MG/ML Oral SuspensionSCD4
199106pyrantel pamoate 144 MG per 1 ML Oral SuspensionSY4
199106pyrantel pamoate 144 MG/ML (pyrantel base 50 MG/ML) Oral SuspensionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-101-112023-07-28C16284748780-19d75b9d0-8866-f424-e053-dadaa90a57cePARASITOL
53145-101-112021-08-09C16284748780-19d75b9d0-8866-f424-e053-dadaa90a57cePARASITOL
53145-101-112020-01-31C16284748780-19d75b9d0-8866-f424-e053-dadaa90a57cePARASITOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-101-01PARASITOL30 mL in 1 BOTTLESUSPENSION304
53145-101-11PARASITOL1 in 1 BOXSUSPENSION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PYRANTEL PAMOATEACTIVE INGREDIENT81BK194Z5M1
PYRANTELACTIVE MOIETY4QIH0N49E71
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19X1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-10153145-101-01, 53145-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
PYRANTEL PAMOATE81BK194Z5MACTIM

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 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XSUSPENSION / ORAL50.07 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XSUSPENSION / ORAL50.07 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XSUSPENSION / ORAL50.07 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
PARASITOLPYRANTEL PAMOATEMenper Distributors Inc.cd5eb4c9-d0f0-4be7-84eb-88ebc4632dc62025-07-22WarningsExact identifier
ndc (package): 53145-101-01
ndc (package): 53145-101-11
ndc (product): 53145-101
ndc11 (package): 53145010111
ndc11 (package): 53145010101
spl id: 3a8a63ea-ec4f-58e7-e063-6394a90a3110
spl set id: cd5eb4c9-d0f0-4be7-84eb-88ebc4632dc6

Reported adverse events (FAERS/openFDA)#

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