Skip to Content

← See all Pin X brands

Pin X by Quartz Specialty Pharmaceuticals, LLC

Dosage form: tablet, chewable
Ingredients: PYRANTEL PAMOATE 250mg
Labeler: Quartz Specialty Pharmaceuticals, LLC
NDC Code: 13893-689

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.

Pin-X®
Chewable Tablets

PINWORM TREATMENT

DESCRIPTION

Each chewable tablet for oral administration contains:

Pyrantel pamoate ..................................720.5 mg
(equivalent to 250 mg pyrantel base)


Also contains aspartame, citric acid, colloidal silicon dioxide, croscarmellose sodium, dextrose, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, sorbitol and stearic acid.

CLINICAL PHARMACOLOGY

Pin-X® has demonstrated anthelmintic activity against Enterobius vermicularis (pinworm) and Ascaris lumbricoides (common roundworm). The anthelmintic action is probably due to the neuromuscular blocking property of the drug. Pin-X® is partially absorbed after an oral dose. Plasma levels of unchanged drug are low. Peak levels (0.05 - 0.13 micrograms per milliliter) are reached in 1-3 hours. Quantities greater than 50% of administered drug are excreted in feces as the unchanged form, whereas only 7% or less of the dose is found in urine as the unchanged form of the drug and its metabolites.

Symptoms suggestive of pinworm infestation:

Pruritis Ani (itching in the anal area), insomnia, gastrointestinal distress, irritability, enuresis (bed wetting) and secondary infection due to localized scratching are symptoms of pinworms. However, you should make a visual inspection and confirmation of the pinworms before using this product.

How to find and identify the pinworm:

A pinworm is a small round worm that lives in the body of other animals. They are 1/4 to 1/2 inch long and have white bodies and pointed tails. There are several kinds of pinworms, however, only one kind, Enterobius vermicularis, commonly infects human beings. The worms can usually be detected during the hours of sleep when the worm migrates out of the anus onto the surrounding skin.

The life cycle of the pinworm:

The young worms live in the upper part of the large intestine. When they are ready to lay eggs, they crawl down the rectum and out the intestinal opening called the anus, usually at night. They lay eggs on the surrounding skin. This movement causes swelling and severe itching.

How pinworms are spread and how to avoid spreading:

The eggs fall off into the bedding or clothing and may be picked up under the fingernails in scratching. If the eggs are swallowed, they reach the intestine and become adult pinworms. Therefore, to avoid the spreading of pinworms all areas should be as clean as possible.

INDICATIONS AND USAGE

For the treatment of pinworms.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients.

WARNINGS

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.

Abdominal cramps, nausea, vomiting, diarrhea, headache, 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 a doctor.

PRECAUTION

Information for Patients

Phenylketonurics

Pin-X® Chewable Tablets contain phenylalanine 11.8 mg per tablet.

DIRECTIONS FOR USE

Read package insert carefully before taking this medication. 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. 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.

Adults 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. Dosage information is summarized on the following schedule:

WeightDosage (taken as a single dose)
Less than 25 pounds (11 kg)
or under 2 years old

Do not use unless directed
by a doctor

25 to 37 pounds (11 to 16 kg)1/2 tablet
38 to 62 pounds (17 to 28 kg)1 tablet
63 to 87 pounds (29 to 39 kg)1 1/2 tablets
88 to 112 pounds ( 40 to 50 kg)2 tablets
113 to 137 pounds (51 to 62 kg)2 1/2 tablets
138 to 162 pounds (63 to 73 kg)3 tablets
163 to 187 pounds (74 to 84 kg)3 1/2 tablets
over 187 pounds (over 84 kg)4 tablets

HOW SUPPLIED

Pin-X® Chewable Tablets are supplied as round, flat faced, orange color, orange flavored chewable tablets with “Pin-X” debossed over a score line on one side and plain on the reverse side, in bottles of 12.

Store at 15°-30°C (59°-86°F).

Distributed by:
QUARTZ SPECIALTY PHARMACEUTICALS, LLC
130 Vintage Drive
Huntsville, Alabama 35811

8182505
Rev 12/10
R2



PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
PIN X 
pyrantel pamoate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13893-689
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL250 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
DEXTROSE, UNSPECIFIED FORM 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
SORBITOL 
STEARIC ACID 
Product Characteristics
ColorORANGEScore2 pieces
ShapeROUNDSize22mm
FlavorORANGEImprint CodePIN;X
Contains    
Packaging
#Item CodePackage Description
1NDC:13893-689-081 BOTTLE, PLASTIC in 1 CARTON
112 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart357B10/31/2011
Labeler - Quartz Specialty Pharmaceuticals, LLC (830836958)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(13893-689)

Revised: 09/2015
 
Quartz Specialty Pharmaceuticals, LLC

← See all Pin X brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide