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Exclusively distributed by
OPMX
Chula Vista, CA 91910
Questions or comments:
619-600-5632
MADE IN INDIA
Lombrix Tablet
FDA Label NDC 69729-807
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Lombrix (NDC 69729-807). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each uncoated tablet)
Pyrantel Pamoate USP 180 mg (equivalent to 62.5mg of pyrantel base)
Otc - Purpose
Purpose
Antihelmintic
Indications & Usage
Use:for the treatment of pinworms
Warnings
Warnings:Do not exceed recommended dosage
Otc - Ask Doctor
Ask a doctor before use if:
- you're pregnant
- you're nursing a baby
- you have liver disease
Otc - When Using
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of overdose, get medical help or contact a poison control center rightaway.
Dosage & Administration
Directions:
Adults, children 12 years of age and over, and children 2 years to under 12 years: Oral dossage is a single dose of 5 mg of pyrantel base per pound or 11 mg of pyrantel base per kilogram of body weight. Do not Exceed 1 gram (1000mg). Children Under 25lbs. or 2yrs: Don't use unless directed by a doctor.
READ PACKAGE INSERT CAREFULLY BEFORE TAKING THIS MEDICATION
| Weight | Dosage(taken as a single dose) |
| Less than 25 lb. or under 2 yrs. old | Do not use unless directed by a doctor |
| 25-37 lb. | 2 tablets |
| 38-62 lb. | 4 tablets |
| 63-87 lb. | 6 tablets |
| 88-112 lb. | 8 tablets |
| 113-137 lb. | 10 tablets |
| 138-162 lb. | 12 tablets |
| 163-187 lb. | 14 tablets |
| 188 lb & over | 16 tablets |
Storage And Handling
Other information:
- store at 15°-30°C (59°-86°F)
Inactive Ingredient
Inactive ingredients:Colloidal silicon dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, talc.
Other Safety Information
TAMPER-EVIDENT: DO NOT USE IF THE BLISTER IS CUT OR BROKEN
Package Label.Principal Display Panel
NDC 69729-807-10
Lombrix
Pyrantel Pamoate Tablets 180 mg
TREATMENT FOR PINWORMS
- Recommended By Health Care Professionals ForThe Entire Family
10 Tablets
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