Leader Ready to Use Mineral Oil Laxative — v6

Leader Ready to Use Mineral Oil Laxative

7 Views

Version

v6

Effective date

September 29, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
c0bcd9e0-55c5-441d-a847-d77cec1c1972
Set ID
b8494d02-8a7d-47b4-80b0-b8ab51b625fd
Application numbers
M007
Product NDCs
70000-0109
Package NDCs
70000-0109-1
Original packager NDCs

Names & Manufacturers

Brand names
Leader Ready to Use Mineral Oil Laxative
Generic names
MINERAL OIL
Manufacturer names
Cardinal Health
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
MINERAL OIL
Routes
RECTAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
T5L8T28FGP
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each 118 mL delivered dose) Mineral oil 100%
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have abdominal pain, nausea, or vomiting if you have a sudden change in bowel habits that persists over a period of 2 weeks if you have already used a laxative for more than 1 week if constipation continues after one week of use, contact your doctor
Dosage And Administration (1)

Sequence 1

Directions Single daily dose (per 24 hours). adults & children 12 years and over 1 bottle once daily children 2 to under 12 years 1/2 bottle once daily discard unused portion children under 2 years DO NOT USE
Dosage And Administration Table (1)

Sequence 1

adults & children 12 years and over1 bottle once daily
children 2 to under 12 years1/2 bottle once daily discard unused portion
children under 2 yearsDO NOT USE
Inactive Ingredient (1)

Sequence 1

Inactive ingredients none
Indications And Usage (1)

Sequence 1

Uses for relief of occasional constipation for relief of fecal impaction for removal of residue after barium administration
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton LEADER ™ NDC 70000-0109-1 Ready-To-Use Enema Mineral Oil Lubricant Laxative Sodium Free For Relief Of: Occasional Constipation Comfortable, Lubricated Tip Works in Minutes Not Made With Natural Rubber Latex COMPARE TO FLEET ® MINERAL OIL ENEMA active ingredient* 1 BOTTLE 100% Money Back Guarantee 4 .5 FL OZ (133 mL) PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breastfeeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Lubricant laxative
Questions (1)

Sequence 1

Questions or comments? 1-866-323-0107
Spl Product Data Elements (1)

Sequence 1

Leader Ready to Use Mineral Oil Laxative mineral oil MINERAL OIL MINERAL OIL
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017
Stop Use (1)

Sequence 1

Stop use and ask a doctor if you have rectal bleeding or no bowel movement within 15 minutes of using this product you need to use a laxative for more than one week These symptoms may indicate a serious condition.
Storage And Handling (1)

Sequence 1

Other information store at 15°-30°C (59°-86°F) this product generally produces a bowel movement in 2 to 15 minutes
Warnings (1)

Sequence 1

Warnings For rectal use only Ask a doctor before use if you have abdominal pain, nausea, or vomiting if you have a sudden change in bowel habits that persists over a period of 2 weeks if you have already used a laxative for more than 1 week if constipation continues after one week of use, contact your doctor Stop use and ask a doctor if you have rectal bleeding or no bowel movement within 15 minutes of using this product you need to use a laxative for more than one week These symptoms may indicate a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

OpenFDA raw payload

{'application_number': ['M007'],
 'brand_name': ['Leader Ready to Use Mineral Oil Laxative'],
 'generic_name': ['MINERAL OIL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cardinal Health'],
 'package_ndc': ['70000-0109-1'],
 'product_ndc': ['70000-0109'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['RECTAL'],
 'spl_id': ['c0bcd9e0-55c5-441d-a847-d77cec1c1972'],
 'spl_set_id': ['b8494d02-8a7d-47b4-80b0-b8ab51b625fd'],
 'substance_name': ['MINERAL OIL'],
 'unii': ['T5L8T28FGP']}