PARASITEXX- pyrantel pamoate suspension

Parasitexx by

Drug Labeling and Warnings

Parasitexx by is a Otc medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, All Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient (in each 1 ml) Purpose

• Active Ingredient (in each 1 ml): Purpose
• PYRANTEL PAMOATE: Pinworm Treatment

Inactive Ingredient

acesulfame potassium, cherry flavor, citric acid, glycerin, polysorbate 80, potassium sorbate, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol, water, xanthan gum.

Dosage

Directions Read package insert careful 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, or pinworms are still present after treatment, consult a doctor.

• Less than 26 pounds or under 2 years of age: Do not use unless directed by a doctor
• 25 to 37 pounds: ½ teaspoonful (2.5 ml)
• 38 to 62 pounds: 1 teaspoonful (5 ml)
• 63 to 87 pounds: 1 ½ teaspoonfuls (7.5 ml)
• 88 to 112 pounds: 2 teaspoonfuls (10 ml)
• 113 to 137 pounds: 2 ½ teaspoonfuls (12.5 ml)
• 138 to 162 pounds: 3 teaspoonfuls (15 ml)
• 163 to 187 pounds: 3 ½ teaspoonfuls (17.5 ml)
• 188 pounds and over: 4 teaspoonfuls (20 ml)

Shake well before use. This product can be taken any time of the day, with or without meals. It may be taken alone or with milk or juice. Use of a laxative is not necessary prior to, during, or after medication.

Uses

For the treatment of pinworms.

Warnings

Do not exceed recommended dosage. When using this product abdominal cramps, nausea, diarrhea. Headache, or dizziness sometimes occurs after taking this drug. If this condition persists consult doctor.

ASK DOCTOR

Ask a doctor before use if you have liver disease.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

INDICATIONS & USAGE

Uses for the treatment of pinworns

Keep out of reach of children.

In case of accidental overdose, seek medical attention or contact a Poison Control Center immediately.

Other information

Protect from excessive heat and freezing. Store at room temperature.

Tamper-Evident Feature: do not use if printed seal around bottle neck is torn, broken or missing.

QUESTIONS

Questions? 305-261-8762
Monday – Friday 9am to 5pm EST.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PARASITEXX 
pyrantel pamoate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-134
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	144 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CHERRY (UNII: BUC5I9595W)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-134-05	1 in 1 CARTON	07/01/2017
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part357B	05/01/2017

Labeler - Dannso Corp./d.b.a. Essential Products (059741071)

Registrant - Dannso Corp./d.b.a. Essential Products (059741071)

Establishment
Name	Address	ID/FEI	Business Operations
All Pharma LLC		078572520	MANUFACTURE(70242-134)