Womens Gentle Laxative
FDA Label NDC 72476-960

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Retail Business Services, Llc for the product Womens Gentle Laxative (NDC 72476-960). 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 drug facts, active ingredient (in each softgel), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Softgel)

Bisacodyl (USP) 5 mg

Purpose

Stimulant laxative

Uses

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Otc - Do Not Use

Do not use if you cannot swallow without chewing

Otc - Ask Doctor

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Otc - When Using

When using this product

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and cramps
  • do not use within 1 hour after taking an antacid or milk

Otc - Stop Use

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

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

adults and children 12 years and over1 to 3 tablets in a single daily dose
children 6 to under 12 years of age1 tablet in a single daily dose
children under 6 years of ageask a doctor

Other Information

  • store at 20-25°C (68-77°F)
  • protect from excessive humidity

Inactive Ingredients

dextrose monohydrate, D&C Red #27, FD&C Blue #1, hypromellose, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, methacrylic acid copolymer, methyl cellulose, pregelatinized starch, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

1-888-333-9792

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