Senna-lax
FDA Label NDC 68788-6442

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Senna-lax (NDC 68788-6442). 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, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

(in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

Warnings

Do not use

  • laxative products for longer than one week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • stomach pain, nausea, or vomiting, noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop Use And Ask A Doctor If

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative
  •  These may indicate a serious condition.

If Pregnant Or Breast-Feeding,

ask a health care professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • preferable at bedtime or a directed by a doctor
  • adults and children 12 years of age and older: 2 tablets once a day: maximum of 4 tablets once a day
  • children (6-12 years) 1tablet once a day: maximum 2 tablets once a day
  • children (2-6 years) ½ tablet once a day: maximum 1 tablet once a day
  • children under 2 years of age: Ask a doctor

    • Other information

    • Store at room temperature, USP
    • Each tablet contains: Calcium 20 mg

Inactive Ingredient

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil and Polyethylene Gycol

Questions or comments? (800) 616-2471

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Product color may slightly vary due to natural changes of ingredients

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com

Distributed By:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150

Rev. 10/15

Repackaged By: Preferred Pharmaceuticals Inc.

Principal Display Panel

Senna-Lax

(Standardized Senna Concentrate)

8.6 mg Sennosides

100 Tablets

Senna Lax (Image 01)

Senna Lax (Image 01)

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