Laxative Tablet, Film Coated
FDA Label NDC 63561-0186

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Granulation Technology, Inc. for the product Laxative (NDC 63561-0186). 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 other, otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (in each tablet)
Sennosides, 25 mg

Otc - Purpose

Purpose

Stimulant Laxative

Uses

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 hours

Warnings

Otc - Do Not Use

Do not uselaxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Otc - Ask Doctor

Ask a doctor before use if you havenoticed a sudden change in bowel habits that persists over a period of 2 weeks.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

Otc - When Using

When using this productdo not use for a period longer than 1 week.

Otc - Stop Use

Stop use and ask a doctor ifrectal bleeding or failure to have a bowel movement occur after use of a laxative. These may 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.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • swallow tablet (s) with a glass of water.
  • swallow tablet (s) whole, do not crush, break, or chew.
    • AgeDosage
    adults and children 12 years of age and over2 tablets once or twice daily
    children 6 to under 12 years1 tablet once a day or twice daily
    children under 6 yearsAsk a doctor

Other Information

  • Each tablet contains:Calcium 40 mg, Magnesium 5 mg
  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Use by expiration date on package

Inactive Ingredients

croscarmellose sodium,dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, yellow iron oxide, FD&C blue 1 lake

Otc - Questions

Questions or comments?


call 1-973-276-0740

Principal Display Panel

NDC 63561-0186-9

Laxative Tablets Label

SENNOSIDES, 25 mg / STIMULANT LAXATIVE

Compare to ex.lax ® Maximum Strength Active Ingredient

90 Film-Coated Tablets

* Please review the disclaimer below.