FDA Label for Leader Ready To Use Saline Laxative
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USE
- WARNINGS
- DOSAGE WARNING
- ASK A DOCTOR BEFORE USE IF YOU
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF YOU HAVE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 133 ML BOTTLE CARTON
Leader Ready To Use Saline Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
Otc - Purpose
| Active ingredients (in each 118 mL delivered dose) | Purpose |
|---|---|
| Dibasic sodium phosphate 7 g | Saline laxative |
| Monobasic sodium phosphate 19 g | Saline laxative |
Use
- for relief of occasional constipation
Warnings
For rectal use only
Dosage Warning
Using more than one enema in 24 hours can be harmful.
Ask A Doctor Before Use If You
- are on a sodium-restricted diet
- have abdominal pain, nausea, or vomiting
- have kidney disease, heart problems, or are dehydrated
- are 55 years old or older
- have noticed a sudden change in bowel habits that lasts over 2 weeks
- have already used a laxative for more than 1 week
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
When Using This Product
- do not use more than directed. Serious side effects may occur from excess dosage.
- do not use for more than 3 days
- do not use if taking another sodium phosphates product
Stop Use And Ask A Doctor If You Have
- rectal bleeding
- symptons of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)
- no bowel movement or no liquid comes out of the rectum after 30 minutes
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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)
Directions
Do not use more unless directed by a doctor. See Warnings.
Single daily dosage (per 24 hours).
| adults & children 12 years and over | one bottle once daily |
| children 2 to under 12 years | 1/2 bottle once daily discard unused portion |
| children under 2 years | DO NOT USE |
Do not use if taking another sodium phosphates product.
Other Information
- each 118 mL contains: sodium 4.4g
- store at room temperature 15°-30°C (59°-86°F)
- this product generally produces a bowel movement in 1 to 5 minutes
- additional liquids by mouth are recommended while taking this product
Inactive Ingredients
benzalkonium chloride, disodium EDTA, purified water
Questions Or Comments?
1-866-323-0107
Principal Display Panel - 133 Ml Bottle Carton
NDC 70000-0108-1
LEADER®
Compare to Fleet®
Saline Enema
active ingredients*
READY-TO-USE
Enema
Saline Laxative
For Relief Of
Occasional
Constipation
Soft, Flexible
Comfort Tip
Latex Free
• SATISFACTION •
GUARANTEED
4.5 FL OZ (133 ml)
* Please review the disclaimer below.