Active Ingredient (In Each Tablet)
Sennosides USP, 25 mg
Laxative Pills
FDA Label NDC 63868-296
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Laxative Pills (NDC 63868-296). 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, 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
- 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 40 mg
- very low sodium
- store between 20-25°C (68-77°F)
Inactive Ingredients
acacia, calcium phosphate dihydrate, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, iron oxide*, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid*, sugar,, talc, titanium dioxide
Questions Or Comments?
Call 1-248-449-9300 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredient in ex-lax® MAXIMUM STRENGTH
Maximum Strength
Laxative
Stimulant Laxative
Sennosides USP, 25 mg
Gentle, Dependable Overnight Relief
Tablets
*This product is not manufactured or distributed by GlaxoSmithKline Ex-Lax®.plc, distributor of ex-lax®.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
Product Label
QUALITY CHOICE Maximum Strength Laxative
* Please review the disclaimer below.
