Version
v1
Lombrix — v1
Lombrix
4 Views
Effective date
September 24, 2025
Original packager
Yes
Sections captured
15
Identifiers
- Document ID
- 3f94048f-d2bd-5a1a-e063-6294a90adf52
- Set ID
- 3f940481-8e75-0bc7-e063-6394a90af1cd
- Application numbers
- M024
- Product NDCs
- 69729-807
- Package NDCs
- 69729-807-10
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- Lombrix
- Generic names
- PYRANTEL PAMOATE
- Manufacturer names
- OPMX LLC
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- PYRANTEL PAMOATE
- Routes
- ORAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- —
- UNII
- 81BK194Z5M
- UPC
- 0810053181768
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active ingredient (in each uncoated tablet) Pyrantel Pamoate USP 180 mg (equivalent to 62.5mg of pyrantel base)
Ask Doctor (1)
Sequence 1
Ask a doctor before use if: you're pregnant you're nursing a baby you have liver disease
Dosage And Administration (1)
Sequence 1
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
Dosage And Administration Table (1)
Sequence 1
| 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 |
Inactive Ingredient (1)
Sequence 1
Inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, talc.
Indications And Usage (1)
Sequence 1
Use: for the treatment of pinworms
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center rightaway.
Other Safety Information (1)
Sequence 1
TAMPER-EVIDENT: DO NOT USE IF THE BLISTER IS CUT OR BROKEN
Package Label Principal Display Panel (1)
Sequence 1
NDC 69729-807-10 Lombrix Pyrantel Pamoate Tablets 180 mg TREATMENT FOR PINWORMS Recommended By Health Care Professionals ForThe Entire Family 10 Tablets lo
Purpose (1)
Sequence 1
Purpose Antihelmintic
Spl Product Data Elements (1)
Sequence 1
Lombrix PYRANTEL PAMOATE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE CROSPOVIDONE CROSCARMELLOSE SODIUM POVIDONE, UNSPECIFIED POTASSIUM SORBATE SILICON DIOXIDE MAGNESIUM STEARATE TALC POLYETHYLENE GLYCOL 6000 PYRANTEL PAMOATE PYRANTEL G
Spl Unclassified Section (2)
Sequence 1
Drug Facts
Sequence 2
Exclusively distributed by OPMX Chula Vista, CA 91910 Questions or comments: 619-600-5632 MADE IN INDIA
Storage And Handling (1)
Sequence 1
Other information: store at 15°-30°C (59°-86°F)
Warnings (1)
Sequence 1
Warnings: Do not exceed recommended dosage Ask a doctor before use if: you're pregnant you're nursing a baby you have liver disease 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 rightaway.
When Using (1)
Sequence 1
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.
OpenFDA raw payload
{'application_number': ['M024'],
'brand_name': ['Lombrix'],
'generic_name': ['PYRANTEL PAMOATE'],
'is_original_packager': [True],
'manufacturer_name': ['OPMX LLC'],
'package_ndc': ['69729-807-10'],
'product_ndc': ['69729-807'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['ORAL'],
'spl_id': ['3f94048f-d2bd-5a1a-e063-6294a90adf52'],
'spl_set_id': ['3f940481-8e75-0bc7-e063-6394a90af1cd'],
'substance_name': ['PYRANTEL PAMOATE'],
'unii': ['81BK194Z5M'],
'upc': ['0810053181768']}