PYRANTEL PAMOATE- pinwormtreatment 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.

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Active ingredient (in each 1 tsp)

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

 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)

Other information

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

IndicationFor 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

WEIGHTDOSAGE (TAKEN AS A SINGLE DOSE)
Less than 25 Pounds or under 2 years oldDo not use unless directed by a physician
25 to 37 Pounds½ teaspoonful (125 mg)
38 to 62 Pounds1 teaspoonful (250 mg)
63 to 87 Pounds1½ teaspoonfuls (375 mg)
88 to 112 Pounds2 teaspoonfuls (500 mg)
113 to 137 Pounds2½ teaspoonfuls (625 mg)
138 to 162 Pounds3 teaspoonfuls (750 mg)
163 to 187 Pounds3½ teaspoonfuls (875 mg)
188 Pounds and over4 teaspoonfuls (1000 mg)

Other information

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:

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

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

PYRANTEL PAMOATE 
pinwormtreatment suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13985-918
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
VANILLA (UNII: Q74T35078H)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13985-918-16473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/19/2017
2NDC:13985-918-32946.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart357B04/19/2017
Labeler - MWI Veterinary Supply, Inc. (019926120)
Registrant - Neogen Corporation - Mercer Rd. (042125879)
Establishment
NameAddressID/FEIBusiness Operations
Neogen Corporation - Mercer Rd.042125879analysis(13985-918) , label(13985-918) , manufacture(13985-918)
Establishment
NameAddressID/FEIBusiness Operations
minsheng group shaoxing pharmaceutical co. ltd544607919api manufacture(13985-918)

Revised: 7/2023
Document Id: 00f1ac7a-2ae0-665a-e063-6394a90aca9f
Set id: 133b5e91-7f2f-4af8-8536-c5ecaaf56017
Version: 7
Effective Time: 20230720
 
MWI Veterinary Supply, Inc.