PYRANTEL PAMOATE- pyrantel pamoate suspension 
ProMex 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.

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Pyrantel Pamoate

Drug Facts

Active Ingredient (in each 1mL)

Pyrantel Pamoate 144 mg/mL
(50mg pyrantel base per mL)

Purpose

Anthelmintic

Use

for the treatment of pinworms.

Warnings

*Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occurs 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

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. Do not exceed 1 gram (1000 mg).

WeightDosage (Taken as a single dose)
Under 25 lbs or 2 yrs.Don't use unless directed by a doctor
25-37 lbs½ teaspoonful
38-62 lbs1 teaspoonful
63-87 lbs1 ½ teaspoonful
88-112 lbs2 teaspoonful
113-137 lbs2 ½ teaspoonful
138-162 lbs3 teaspoonful
163-187lbs3 ½ teaspoonful
over 188 lbs4 teaspoonful

*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.

Keep out of Reach of Children. In case of accidental overdose/ingestion contact a poison control center immediately.

Inactive Ingredients

Purified Water, Glycerin, Sugar, Flavor, Xanthan Gum, Citric Acid, Sodium Benzoate and Potassium Sorbate

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

VERMISOL

SUSPENSION

1 oz (30 ml)

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

PYRANTEL PAMOATE 
pyrantel pamoate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1770
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrantel Pamoate (UNII: 81BK194Z5M) (Pyrantel - UNII:4QIH0N49E7) Pyrantel144 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Sucrose (UNII: C151H8M554)  
Xanthan Gum (UNII: TTV12P4NEE)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58988-1770-11 in 1 CARTON09/27/2002
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart357B09/27/2002
Labeler - ProMex LLC (789974388)

Revised: 1/2022
Document Id: d804e4d7-ff72-4250-8ce0-904254f81156
Set id: e68c503a-6f79-4f83-a6f3-c12a13fb06a0
Version: 4
Effective Time: 20220125
 
ProMex LLC