MedPath

pinworm treatment

pinworm treatment-a+ health

Approved
Approval ID

3cf96d04-e8bc-31af-e063-6294a90a0db8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

BIONPHARMA INC.

DUNS: 079637826

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

pyrantel pamoate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69452-515
Application NumberM024
Product Classification
M
Marketing Category
C200263
G
Generic Name
pyrantel pamoate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (15)

CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
METHYLCELLULOSEInactive
Code: Z944H5SN0H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PYRANTEL PAMOATEActive
Quantity: 144 mg in 1 mL
Code: 81BK194Z5M
Classification: ACTIM
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/25/2025

bottle label 16oz

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-front

bottle-back

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/22/2025

Use

for the treatment of pinworns

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/22/2025

Purpose

Anthelimintic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/22/2025

Warnings

Do not exceed recommended dosage

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/22/2025

Ask a doctor before use if

■ you are pregnant ■ have liver disease

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/22/2025

When using this product

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/22/2025

Keep out of reach of children.

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/22/2025

Active ingredient (in each mL)

Pyrantel Pamoate 144mg/mL

(the equivalent of 50mg pyrantel base)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/22/2025

Directions

■ 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.old

Do 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 over

4 teaspoonfuls

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/22/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/22/2025

Inactive ingredients

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/22/2025

Questions or comments?

call toll-free1-888-235-2466

SPL PATIENT PACKAGE INSERT SECTION

LOINC: 42230-3Updated: 8/22/2025

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.

Weight

Dosage (taken as a single dose)

Less than 25 pounds or under 2 years old

consult a doctor

25 to 37 pounds

½ teaspoonful

38 to 62 pounds

1 teaspoonful

63 to 87 pounds

1½ teaspoonfuls

88 to 112 pounds

2 teaspoonfuls

113 to 137 pounds

2½ teaspoonfuls

138 to 162 pounds

3 teaspoonfuls

163 to 187 pounds

3½ teaspoonfuls

188 pounds and over

4 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

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