PYRANTEL PAMOATE (PINWORMTREATMENT) SUSPENSION [MWI VETERINARY SUPPLY, INC.]

PYRANTEL PAMOATE (PINWORMTREATMENT) SUSPENSION [MWI VETERINARY SUPPLY, INC.]
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NDC 13985-918-16, 13985-918-32
Set ID 133b5e91-7f2f-4af8-8536-c5ecaaf56017
Category HUMAN OTC DRUG LABEL
Packager MWI Veterinary Supply, Inc.
Generic Name
Product Class
Product Number
Application Number PART357B
  • 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

  • PREGNANCY OR BREAST FEEDING

    If you are pregnant or have liver disease, do not take this product unless directed by a physician.

  • WHEN USING

    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 859-254-1221 or toll-free 800-621-8829.

  • USER SAFETY WARNINGS

    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

    Use for the treatment of pinworms.

    Warnings

    Keep out of reach of children. In case of accidental overdose, seek professional assistance 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). 
    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)
    • 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 859-254-1221 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.
  • PRINCIPAL DISPLAY PANEL

    NDC 13985-918-16

    Pyrantel Pamoate Suspension

    (Pyrantel base: 50 mg / mL)

    Pinworm Treatment

    apexa

    AP 704040 16 oz (473.2 mL)

    16oz Bottle

  • PRINCIPAL DISPLAY PANEL

    NDC 13985-918-32

    Pyrantel Pamoate Suspension

    (Pyrantel base: 50 mg / mL)

    Pinworm Treatment

    apexa

    AP 704041 32 oz (946.4 mL)

    32oz Bottle

  • INGREDIENTS AND APPEARANCE
    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)

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