The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy Inc. for the product Pinworm Treatment (NDC 59779-538). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding pinworm treatment, other safety information, active ingredient (in each 1 ml), purpose, use, warnings, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
NDC 59779-538-02
PYRANTEL PAMOATE
(PYRANTEL BASE 50 mg/mL)
Ages 2 to Adult
Caramel Flavored Liquid
Actual Product Size on Back Panel
FAMILY SIZE
2 FL OZ (60 mL)
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING OR IF CARTON IS OPENED.
Pyrantel pamoate 144 mg
(equivalent to 50 mg pyrantel base)
Pinworm treatment
for the treatment of pinworms.
Do not exceed recommended dosage.
Ask a doctor before use if:
When using this product abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these symptoms persist, consult a doctor.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Under 25 lbs or under age 2, consult a doctor
25-37 lbs..... 1/ 2 tsp
36-62 lbs.....1 tsp
63-87 lbs.....1 1/ 2 tsps
88-112 lbs....2 tsps
113-137 lbs.....2 1/ 2 tsps
138-162 lbs.....3 tsps
163-187 lbs.....3 1/ 2 tsps
over 187 lbs.....4 tsps
acesulfame potassium, citric acid, flavor, methylparaben, microcrystalline cellulose, polysorbate 80, propylene glycol, propylparaben, purified water, sodium benzoate, sodiumcarboxymethylcellulose, sodium citrate, sorbitol solution
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