Active Ingredient (In Each Tablet)
Sennosides USP, 25 mg
Laxative Tablet, Film Coated
FDA Label NDC 76162-773
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Laxative (NDC 76162-773). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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 are, when using this product,, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 any other 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
- do not take more than directed
- swallow tablet(s) with a glass of water
- swallow tablet(s) whole; do not crush, break, or chew
| adults and children 12 years and over | 2 tablets once or twice daily |
| children 6 to under 12 years | 1 tablet once or twice daily |
| children under 6 years | ask a doctor |
Other Information
- each tablet contains: calcium 35 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium lauryl sulfate, sucrose, talc, titanium dioxide
Questions Or Comments?
1-888-423-0139
Principal Display Panel
+TopCare®
health
NDC 76162-773-08
COMPARE TO EX•LAX®
MAXIMUM STRENGTH
ACTIVE INGREDIENT†
MAXIMUM STRENGTH
Laxative
SENNOSIDES USP, 25 mg • STIMULANT LAXATIVE
• Senna Ingredient
• Gentle, Dependable Constipation Relief
24 COATED TABLETS
Gentle, Dependable
Constipation Relief
actual
size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
†This product is not manufactured or distributed
by GSK Consumer Healthcare SARL, owner of the
registered trademark ex•lax® Maximum Strength.
QUALITY GUARANTEED
50844 ORG082177308
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0522
QUESTIONS? 1-888-423-0139
[email protected]
www.topcarebrand.com
Topcare 44-773 (Topcare 44 773 1)
* Please review the disclaimer below.
