pinworm treatment

Manufacturer
BIONPHARMA INC. | OrBion Pharmaceuticals Private Limited
Effective date
2026-01-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:34

Label at a glance#

Productpinworm treatment
Active ingredientPYRANTEL PAMOATE
Label structure15 sections

Dosage and administration

■ shake well before use ■ read bottle label and package insert carefully before taking this medication ■ treat the entire household unless otherwise advised. See Warnings ■ do not repeat treatment unless directed by a doctor ■ 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 ■...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each mL)

Pyrantel Pamoate 144mg/mL

(the equivalent of 50mg pyrantel base)

OTC - PURPOSE SECTION

Purpose

Anthelimintic

Use

INDICATIONS & USAGE SECTION

for the treatment of pinworns

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

■ you are pregnant ■ have liver disease

When using this product

OTC - WHEN USING SECTION

abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these symptoms persist, consult a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ shake well before use

■ read bottle label and package insert carefully before taking this medication

■ treat the entire household unless otherwise advised. See Warnings

■ do not repeat treatment unless directed by a doctor

■ 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

■ if signs of pinworms persist after treatment, consult a doctor

Weight

Dosage

(taken as a single dose)

Less than 25 lb. or under 2 yrs.oldDo not use unless directed by a doctor
25-37 lb.1/2 teaspoonful
38-62 lb.1 teaspoonful
63-87 lb.1 1/2 teaspoonfuls
88-112 lb.2 teaspoonfuls
113-137 lb.2 1/2 teaspoonfuls
138-162 lb.3 teaspoonfuls
163-187 lb.3 1/2 teaspoonfuls
188 lb. and over4 teaspoonfuls

Other information

SPL UNCLASSIFIED SECTION

■ Store between 15°C-30°C (59°- 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

banana flavor, citric acid, gylcerin, lecithin, magnesium aluminum silicate, methylcellulose, methylparaben, povidone, propylene glycol, propylparaben, purified water, simethicone, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-235-2466

SPL UNCLASSIFIED SECTION

CAUTION: DO NOT USE IF IMPRINTED SEAL ON BOTTLE IS BROKEN OR MISSING

Distributed by:

BIONPHARMA

Princeton, NJ 08540

MADE IN INDIA

Code: TN/Drugs/TN00002222/2006

949129345

L0001113

R0725

SPL PATIENT PACKAGE INSERT SECTION

READ THIS INSERT CAREFULLY BEFORE TAKING MEDICATION

PINWORM MEDICINE

Pyrantel Pamoate 144 mg/mL
(the equivalent of 50 mg Pyrantel base per mL)


FOR THE TREATMENT OF PINWORMS

DIRECTIONS

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.

Take only according to directions and do not exceed the recommended dosage unless directed by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless directed 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 treatment, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.


Shake well before using.

WeightDosage (taken as a single dose)
Less than 25 pounds or under 2 years oldconsult a doctor
25 to 37 pounds½ teaspoonful
38 to 62 pounds1 teaspoonful
63 to 87 pounds1½ teaspoonfuls
88 to 112 pounds2 teaspoonfuls
113 to 137 pounds2½ teaspoonfuls
138 to 162 pounds3 teaspoonfuls
163 to 187 pounds3½ teaspoonfuls
188 pounds and over4 teaspoonfuls

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.

WARNINGS
Abdominal cramps, nausea, vomiting, diarrhea, headaches, or dizziness, sometimes occur after taking this drug, if any of these conditions persist consult a doctor.

If you are pregnant or have Liver disease, do not take this product unless directed by your doctor.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

OTHER INFORMATION
This brochure will tell you how to identify and treat pinworm infections effectively with pinworm medicine. Many who have pinworms do not have symptoms, however, many will have 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 prominent at night when sleeping. That is why restless sleep is sometimes a sign of pinworms, especially in children. Other symptoms include insomnia, gastrointestinal distress, irritability, enuresis (bed wetting) and secondary infection due to localized scratching. You should treat with pinworm medicine only after you have seen and identified the pinworms.

Pinworms look like tiny white threads. The female pinworm is about 1/2 inch long (the male pinworm is shorter); they live in the bowel. Usually, at night, the female pinworm travels to the rectal opening and lays eggs within the skin folds around the opening. This usually takes place within 1-2 hours after the child has been put to sleep 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.


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 can survive for as long as 3 weeks. Pinworms are highly contagious; therefore, after treatment with pinworm medication you should wash hands and fingernails with soap often during the day in order to prevent spreading to others and reinfection. Wear tight underpants
both day and night. For several days after treatment clean the bedroom floor by vacuuming or damp mopping. After treatment, wash bed linens and night clothes (don't shake them). Keep toilet seats clean.

Distributed by: Bionpharma Inc.

Princeton, NJ 08540

MADE IN INDIA
948026846

L0000896
R0924

carton label 2oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full prescription strength

a+ health TM

pinworm

treatment

pyrantel pamoate

suspension

  • Single dose effectiveness
  • Measuring cup included
  • Doctor recommended

For the entire family (Ages 2 & up)

2 fl. oz. (60 ml)

contains two (2)-1oz bottles

cartoncarton

bottle label 16oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full prescription strength

a+ health TM

pinworm

treatment

pyrantel pamoate

suspension

  • Single dose effectiveness
  • Doctor recommended

For the entire family (Ages 2 & up)

16 fl. oz. (473 ml)

bottle-frontbottle-front

bottle-backbottle-back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199106pyrantel pamoate 144 MG in 1 mL Oral SuspensionPSN2
199106pyrantel pamoate 144 MG/ML Oral SuspensionSCD2
199106pyrantel pamoate 144 MG per 1 ML Oral SuspensionSY2
199106pyrantel pamoate 144 MG/ML (pyrantel base 50 MG/ML) Oral SuspensionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-515-36pinworm treatment30 mL in 1 BOTTLESUSPENSION302
69452-515-38pinworm treatment2 in 1 CARTONSUSPENSION22
69452-515-49pinworm treatment1 in 1 CARTONSUSPENSION12
69452-515-49pinworm treatment30 mL in 1 BOTTLESUSPENSION302
69452-515-88pinworm treatment473 mL in 1 BOTTLESUSPENSION4732

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
69452-51569452-515-36, 69452-515-38, 69452-515-88, 69452-515-49

Ingredients#

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

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

Source Document#

Source XML

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
pinworm treatmentPYRANTEL PAMOATEBIONPHARMA INC.3cf96d04-e8bc-31af-e063-6294a90a0db82026-01-23WarningsExact identifier
ndc (package): 69452-515-49
ndc (package): 69452-515-38
ndc (package): 69452-515-36
ndc (package): 69452-515-88
ndc (product): 69452-515
ndc11 (package): 69452051536
ndc11 (package): 69452051588
ndc11 (package): 69452051538
ndc11 (package): 69452051549
spl id: 48ebc5ed-d3de-80c1-e063-6294a90ac01a
spl set id: 3cf96d04-e8bc-31af-e063-6294a90a0db8

Reported adverse events (FAERS/openFDA)#

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