Equalactin Laxative Tablet
FDA Label NDC 69846-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Numark Brands, Inc for the product Equalactin Laxative (NDC 69846-000). 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 otc - purpose, indications & usage, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active IngredientsPurpose
Calcium polycarbophil 625 mg
(equivalent to 500 mg polycarbophil)		Laxative

Indications & Usage

Use  for relief of occasional constipation and irregularity

This product generally produces bowel movement in 12 - 72 hours.

Warnings

Do not use this product for more than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • abdominal pain
  • nausea
  • vomiting
  • a sudden change in bowel habits over a period of 2 weeks

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking an antibiotic containing tetracycline as this product contains calcium

Stop Use And Ask A Doctor If

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

Otc - Pregnancy Or Breast Feeding

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product

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.

Directions

  • drink a full glass (8 fl. oz.) of liquid with each dose
  • chew tablets thoroughly
  • do not swallow tablets whole
    • adults and children 12 years of age and overup to 8 tablets daily in divided doses of 2 tablets per dose
    children 6 to under 12 years of ageup to 4 tablets daily in divided doses of 1 tablet per dose
    children 2 to under 6 years of ageup to 2 tablets daily in divided doses of 1 tablet per dose
    children under 2 years of ageconsult a doctor

Other Information

  • store at room temperature
  • avoid excessive humidity

Inactive Ingredient

Inactive ingredients  citric acid, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sucralose

Otc - Questions

Questions? 1-800-331-0221

Principal Display Panel

Equalactin® Laxative

Relieves Symptoms of Nervous Stomach
 

  • Irregularity
  • Abdominal Discomfort
  • Loose Bowels
  • Constipation

    • 24 CITRUS FLAVORED CHEWABLE TABLETS

    Relives Symptoms of Nervous Stomach

    Distributed by: NUMARK LABORATORIES INC.
    EDISON, NJ 08818     Rev. 5/11      9002

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