FDA Label for Leader Maximum Strength Laxative
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- USE(S)
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Leader Maximum Strength 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.
Active Ingredients (In Each Tablet)
Calcium sennosides 25 mg
Purpose
Stimulant laxative
Use(S)
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
Do Not Use
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
Ask A Doctor Before Use If You Have
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You
- are taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs
When Using This Product
- do not use for a period longer than 1 week
Stop Use And Ask A Doctor If
- rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions
- Swallow pill(s) with a glass of water
- Swallow pill(s) whole, do not crush, break or chew.
| adults and children 12 years and over | take 2 tablets once or twice daily with a glass of water |
| children 6 to under 12 years | take 1 tablet once or twice daily with a glass of water |
| children under 6 years | ask a doctor |
Other Information
- do not use if individual blister compartments are torn or open
- store at room temperature
- Calcium content: 40 mg per tablet
- Magnesium content: 10mg per tablet
Inactive Ingredients
acacia, anhydrous lactose, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, tartaric acid, titanium dioxide.
Principal Display Panel
LEADER®
Compare to the EX-LAX® Maximum Strength Tablets active ingredient*
Maximum Strength
Laxative
Laxative Stimulant
calcium sennosides, 25mg
Gentle, dependable overnight relief of constipation
24 TABLETS
Distributed By: Cardinal Health
Dublin, Ohio 43017
www.myleader.com
CIN 2740934
* Please review the disclaimer below.