FDA Label for Laxative Pills Maximum Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- 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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Laxative Pills Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Top Care (topco Associates Llc). 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 Ingredient (In Each Tablet)
Sennosides 25 mg
Purpose
Stimulant laxative
Uses
- 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 right away.
Directions
- swallow tablet(s) with a glass of water
- swallow tablet(s) whole, do not crush, break, or chew
adults and children 12 years of age and older | take 2 tablets once or twice daily |
children 6 to under 12 years of age | take 1 tablet once or twice daily |
children under 6 years of age | ask a doctor |
Other Information
- each tablet contains: calcium 50 mg
- very low sodium
- store between 20-25°C (68-77°F)
Inactive Ingredients
acacia, ammonium hydroxide*,calcium carbonate*, calcium phosphate dihydrate*, calcium sulfate anhydrous*, carnauba wax, corn starch*, croscarmellose sodium, dicalcium phosphate*, FD&C blue #1 aluminum lake, hypromellose*, iron oxide*, iron oxide black, iron oxide yellow*, isopropyl alcohol*, kaolin*, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil*, n-butyl alcohol*, polyethylene glycol, polyvinyl alcohol*, povidone*, propylene glycol*, shellac, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, sucrose, talc, titanium dioxide, white wax*
*contains one or more of these ingredients
Questions Or Comments?
Call toll free 1-888-423-0139
Principal Display Panel
MAXIMUM STRENGTH
Laxative Pills
SENNOSIDES 25 mg
- STIMULANT LAXATIVE
- Senna Ingredient
- For Gentle Dependable Overnight Relief
TABLETS
COMPARE TO EX-LAX® MAXIMUM STRENGTH active ingredient**
**This product is not manufactured or distributed by Novartis, owner of the registered trademark Ex-Lax®.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Product Label
TopCare Laxative Pills
* Please review the disclaimer below.