OTC Medication Information: Pyrantel Pamoate

PYRANTEL PAMOATE- pyrantel pamoate suspension
MWI Veterinary Supply, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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).
WEIGHT DOSAGE (TAKEN AS A SINGLE DOSE)
Less than 25 Pounds or under 2 years old Do not use unless directed by a physician
25 to 37 Pounds ½ teaspoonful (125 mg)
38 to 62 Pounds 1 teaspoonful (250 mg)
63 to 87 Pounds 1½ teaspoonfuls (375 mg)
88 to 112 Pounds 2 teaspoonfuls (500 mg)
113 to 137 Pounds 2½ teaspoonfuls (625 mg)
138 to 162 Pounds 3 teaspoonfuls (750 mg)
163 to 187 Pounds 3½ teaspoonfuls (875 mg)
188 Pounds and over 4 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. See Warnings.
  • 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.

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

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

Drug Facts

Active Ingredients

(in each 1 tsp)

Pyrantel base: 250 mg

(as Pyrantel Pamoate)

Purpose

Pinworm treatment

Indication F or 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).
WEIGHT DOSAGE (TAKEN AS A SINGLE DOSE)
Less than 25 Pounds or under 2 years old Do not use unless directed by a physician
25 to 37 Pounds ½ teaspoonful (125 mg)
38 to 62 Pounds 1 teaspoonful (250 mg)
63 to 87 Pounds 1½ teaspoonfuls (375 mg)
88 to 112 Pounds 2 teaspoonfuls (500 mg)
113 to 137 Pounds 2½ teaspoonfuls (625 mg)
138 to 162 Pounds 3 teaspoonfuls (750 mg)
163 to 187 Pounds 3½ teaspoonfuls (875 mg)
188 Pounds and over 4 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 800-525-2022 or toll-free 800-621-8829.

Distributed by:

MWI, Boise, ID 83705

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.

NDC 13985-918-16

Pyrantel Pamoate Suspension

(Pyrantel base: 50 mg / mL)

Pinworm Treatment

apexa

AP 704040 16 oz (473.2 mL)

APEXA Pyrantel Pamoate 16oz Label
(click image for full-size original)

NDC 13985-918-32

Pyrantel Pamoate Suspension

(Pyrantel base: 50 mg / mL)

Pinworm Treatment

apexa

AP 704041 32 oz (946.4 mL)

APEXA Pyrantel Pamoate 32oz Label
(click image for full-size original)
PYRANTEL PAMOATE
pinwormtreatment suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13985-918
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
SODIUM BENZOATE
SUCROSE
VANILLA
WATER
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13985-918-16 473.2 mL in 1 BOTTLE, PLASTIC None
2 NDC:13985-918-32 946.4 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part357B 04/19/2017
Labeler — MWI Veterinary Supply, Inc. (019926120)
Registrant — Neogen Corporation — Mercer Rd. (042125879)
Establishment
Name Address ID/FEI Operations
Neogen Corporation — Mercer Rd. 042125879 analysis (13985-918), label (13985-918), manufacture (13985-918)
Establishment
Name Address ID/FEI Operations
minsheng group shaoxing pharmaceutical co. ltd 544607919 api manufacture (13985-918)

Revised: 07/2023 MWI Veterinary Supply, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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