Label: PARASITOL- pyrantel pamoate suspension
- NDC Code(s): 53145-101-01, 53145-101-11
- Packager: Menper Distributors Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 9, 2021
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless direct by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless direct 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 treatmen, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.
Weight Single Dose Less than 25 pounds or under 2 years of age Do not use unless directed by a doctor 25 to 37 pounds 1/2 teaspoonful (2.5 mL) 38 to 62 pounds 1 teaspoonful (5 mL) 63 to 87 pounds 1 1/2 teaspoonfuls (7.5 mL) 88 to 112 pounds 2 teaspoonfuls (10 mL) 113 to 137 pounds 2 1/2 teaspoonfuls (12.5 mL) 138 to 162 pounds 3 teaspoonfuls (15 mL) 163 to 187 pounds 3 1/2 teaspoonfuls (17.5 mL) 188 pounds and over 4 teaspoonfuls (20 mL)
Shake well before use. 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.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
pyrantel pamoate suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-101 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) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-101-11 1 in 1 BOX 01/01/2013 1 NDC:53145-101-01 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 01/01/2013 Labeler - Menper Distributors Inc. (101947166)