FDA.reportPublic FDA data

PRONTO ® PLUS Pyrantel Pamoate Suspension Pinworm Treatment

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2010-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:39

Label at a glance#

ProductPronto Plus Pinworm Treatment
Active ingredientPyrantel pamoate
Label structure11 sections

Dosage and administration

read package insert carefully before using. Use only according to directions. Do not exceed the recommended dosage unless directed by a doctor. shake well before using adults and children 2 years of age and older: dose one time as a single dose; do not repeat treatment unless directed by a doctor. find the right dose on chart below. Use weight to dose. use enclosed dosing cup. Do not use with any other device. tak...

Storage and handling

The maximum dosage listed (4 TSP) contains 16 mg of sodium. Keep carton for full drug facts. Store at 15°C - 25°C (59°F - 77°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each ½ TSP)

OTC - ACTIVE INGREDIENT SECTION

Pyrantel pamoate 360 mg

(equivalent to 125mg / ½ TSP pyrantel base)

Purpose

OTC - PURPOSE SECTION

Pinworm treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of pinworms

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • you are pregnant
  • you have liver disease

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose Warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • read package insert carefully before using. Use only according to directions. Do not exceed the recommended dosage unless directed by a doctor.
  • shake well before using
  • adults and children 2 years of age and older: dose one time as a single dose; do not repeat treatment unless directed by a doctor.
  • find the right dose on chart below. Use weight to dose.
  • use enclosed dosing cup. Do not use with any other device.
  • take any time of day, with or without meals. May be taken alone or with milk or fruit juice. Use of a laxative is not needed before, during, or after taking Pronto Plus.
  • 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 treatment, ask a doctor
  • if any symptoms or pinworms are still present after treatment, ask a doctor
Weight (lbs)Single Dose (TSP)
Under 25 lbs or under 2 yearsAsk a doctor
25-37½
38-621
63-871 ½
88-1122
113-1372 ½
138-1623
163-1873 ½
188 and over4

Other information

STORAGE AND HANDLING SECTION

The maximum dosage listed (4 TSP) contains 16 mg of sodium. Keep carton for full drug facts. Store at 15°C - 25°C (59°F - 77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

cherry flavor, citric acid, glycerin, lecithin, magnesium aluminum silicate, methylcellulose, povidone, purified water, simethicone, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

SPL UNCLASSIFIED SECTION

Distributed by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749 © 2010 Insight Pharmaceuticals Corporation

PRINCIPAL DISPLAY PANEL - 59 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIPTION STRENGTH

PRONTO®
PLUS

Pyrantel Pamoate Suspension

Pinworm Treatment

Doctor Recommended Ingredient

  • Eliminates Pinworms with One Dose
  • Relieves Itching and Irritation
    from Pinworms
  • Child Resistant Cap

Great Cherry Taste
Sugar Free

2 FL OZ (59 mL)

NEW FAMILY SIZE

Do not use if foil seal under bottle cap imprinted with
"Sealed for Your Protection" is broken or missing.

Principal Display Panel - 59 mL Carton
Principal Display Panel - 59 mL Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1050119Pronto Plus Pinworm 360 MG in 2.5 mL Oral SuspensionPSN1
199106pyrantel pamoate 144 MG in 1 mL Oral SuspensionPSN1
1050119pyrantel pamoate 144 MG/ML Oral Suspension [Pronto Plus Pinworm]SBD1
199106pyrantel pamoate 144 MG/ML Oral SuspensionSCD1
1050119Pronto Plus Pinworm 144 MG/ML (pyrantel base 50 MG/ML) Oral SuspensionSY1
1050119Pronto Plus Pinworm 360 MG per 2.5 ML (pyrantel base 125 MG per 2.5 ML) Oral SuspensionSY1
199106pyrantel pamoate 144 MG per 1 ML Oral SuspensionSY1
199106pyrantel pamoate 144 MG/ML (pyrantel base 50 MG/ML) Oral SuspensionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-240-242019-10-29C16284748780-1960f7f55-d220-8e05-e053-dbdaa90a074aPRONTO ® PLUS Pyrantel Pamoate Suspension Pinworm Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-240-24Pronto Plus Pinworm Treatment1 in 1 CARTONLIQUID11
63736-240-24Pronto Plus Pinworm Treatment24 in 1 CASELIQUID241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-240PRONTO PLUS (PYRANTEL PAMOATE) LIQUID [INSIGHT PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20101214_de68a9d1-96c3-4caf-95aa-d034480b9e59.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Pyrantel pamoateACTIVE INGREDIENT81BK194Z5M1
PyrantelACTIVE MOIETY4QIH0N49E71
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
cyclomethicone 6INACTIVE INGREDIENTXHK3U310BA1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NC1
povidoneINACTIVE INGREDIENTFZ989GH94E1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULR1
sorbitolINACTIVE INGREDIENT506T60A25R1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-24063736-240-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Pyrantel pamoate81BK194Z5MACTIB
Citric Acid Monohydrate2968PHW8QPIACT
GlycerinPDC6A3C0OXIACT
magnesium aluminum silicate6M3P64V0NCIACT
povidoneFZ989GH94EIACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sodium citrate1Q73Q2JULRIACT
saccharin sodiumSB8ZUX40TYIACT
sorbitol506T60A25RIACT
cyclomethicone 6XHK3U310BAIACT

Source Document#

Source XML

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 6 · 323 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sorbitolSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSUSPENSION / RECTAL46.18 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET / SUBLINGUAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
povidonePOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii candidate
88 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
30 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 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
05954178-f513-4240-95b8-a411715f05d3de68a9d1-96c3-4caf-95aa-d034480b9e592010-11-10WarningsExact identifier
spl id: 05954178-f513-4240-95b8-a411715f05d3
spl set id: de68a9d1-96c3-4caf-95aa-d034480b9e59

Reported adverse events (FAERS/openFDA)#

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