PIN-X- pyrantel pamoate suspension
Quartz Specialty Pharmaceuticals, LLC
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®
DESCRIPTION
Each 1 mL of liquid for oral administration contains:
Pyrantel pamoate ..................................144 mg
(equivalent to 50 mg pyrantel base)
Also contains acesulfame potassium, citric acid, flavor, methylparaben, microcrystalline cellulose, polysorbate 80, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol solution.
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.
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.
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:
| Weight | Dosage (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 teaspoonful |
| 38 to 62 pounds (17 to 28 kg) | 1 teaspoonful |
| 63 to 87 pounds (29 to 39 kg) | 1 1/2 teaspoonfuls |
| 88 to 112 pounds ( 40 to 50 kg) | 2 teaspoonfuls |
| 113 to 137 pounds (51 to 62 kg) | 2 1/2 teaspoonfuls |
| 138 to 162 pounds (63 to 73 kg) | 3 teaspoonfuls (1 tablespoonful) |
| 163 to 187 pounds (74 to 84 kg) | 3 1/2 teaspoonfuls |
| over 187 pounds (over 84 kg) | 4 teaspoonfuls |
SHAKE WELL BEFORE USING
HOW SUPPLIED
Pin-X is supplied as an opaque yellow, caramel-flavored suspension, which contains pyrantel pamoate 144 mg (equivalent to 50 mg pyrantel base) per mL, in bottles of 30 mL (1 fl oz), and in bottles of 60 mL (2 fl oz).
Store at 15°-30°C (59°-86°F).
| PIN-X
pyrantel pamoate suspension |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Quartz Specialty Pharmaceuticals, LLC (830836958) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Vintage Pharmaceuticals, LLC | 825839835 | MANUFACTURE(13893-691) | |