Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 2feed33a-3b7f-11c6-6e62-c99150ecfddd
Route
ORAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polycarbophil (625 mg)
Inactive Ingredients
Citric Acid Monohydrate Crospovidone Dextrose, Unspecified Form Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: E Shape: round Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 1986-11-21 Until 2023-03-03

Description

Calcium polycarbophil 625 mg (equivalent to 500 mg polycarbophil)

Purpose

Bulk for mixing Laxative


Medication Information

Purpose

Bulk for mixing Laxative

Description

Calcium polycarbophil 625 mg (equivalent to 500 mg polycarbophil)

Use

for relief of occasional constipation and irregularity. This product generally produces bowel movement in 12 - 72 hours.

Section 50565-1

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

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking an antibiotic containing tetracycline as this product contains calcium
  • taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.
Section 51727-6

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

Section 53413-1

Questions? 1-800-331-0221

Section 53414-9

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

Warnings

Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

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 over up to 8 tablets daily in divided doses of 2 tablets per dose
children 6 to under 12 years of age up to 4 tablets daily in divided doses of 1 tablet per dose
children 2 to under 6 years of age up to 2 tablets daily in divided doses of 1 tablet per dose
children under 2 years of age consult a doctor
Do Not Use

this product for more than 1 week unless directed by a doctor

Other Information
  • each tablet contains calcium 125 mg
  • store at room temperature
  • avoid excessive humidity
Active Ingredients

Calcium polycarbophil 625 mg

(equivalent to 500 mg polycarbophil)

Principal Display Panel

Equalactin®

Bulk Forming Laxative




Relieves Symptoms of Nervous Stomach

  • Irregularity
  • Abdominal Discomfort
  • Loose Bowels
  • Constipation

48 CITRUS FLAVORED CHEWABLE TABLETS



Nervous Stomach (similar to Irritable Bowel), with its symptoms of loose bowels, irregularity, abdominal discomfort and constipation, is caused by water imbalance in the bowel, and afflicts millions. Equalactin provides relief by equalizing the water balance to restore normal bowel movements. When you feel the onset of nervous stomach symptoms, take Equalactin to provide relief and prevent the episode from becoming severe.



Tamper evident: Do not use if carton

is open or if printed seal on blister is

broken or missing.



Distributed by: Numark Brands

138 East Main Street, Suite 201

Kent, OH 44240

Rev 7/25      10001C



EQ-48FC



LOT:







EXP:

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
Ask A Doctor Before Use If You Have
  • abdominal pain
  • nausea
  • vomiting
  • a sudden change in bowel habits over a period of 2 weeks

Structured Label Content

Use

for relief of occasional constipation and irregularity. This product generally produces bowel movement in 12 - 72 hours.

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking an antibiotic containing tetracycline as this product contains calcium
  • taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.
Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions? 1-800-331-0221

Section 53414-9 (53414-9)

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

Purpose

Bulk for mixing Laxative

Warnings

Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

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 over up to 8 tablets daily in divided doses of 2 tablets per dose
children 6 to under 12 years of age up to 4 tablets daily in divided doses of 1 tablet per dose
children 2 to under 6 years of age up to 2 tablets daily in divided doses of 1 tablet per dose
children under 2 years of age consult a doctor
Do Not Use (Do not use)

this product for more than 1 week unless directed by a doctor

Other Information (Other information)
  • each tablet contains calcium 125 mg
  • store at room temperature
  • avoid excessive humidity
Active Ingredients

Calcium polycarbophil 625 mg

(equivalent to 500 mg polycarbophil)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Equalactin®

Bulk Forming Laxative




Relieves Symptoms of Nervous Stomach

  • Irregularity
  • Abdominal Discomfort
  • Loose Bowels
  • Constipation

48 CITRUS FLAVORED CHEWABLE TABLETS



Nervous Stomach (similar to Irritable Bowel), with its symptoms of loose bowels, irregularity, abdominal discomfort and constipation, is caused by water imbalance in the bowel, and afflicts millions. Equalactin provides relief by equalizing the water balance to restore normal bowel movements. When you feel the onset of nervous stomach symptoms, take Equalactin to provide relief and prevent the episode from becoming severe.



Tamper evident: Do not use if carton

is open or if printed seal on blister is

broken or missing.



Distributed by: Numark Brands

138 East Main Street, Suite 201

Kent, OH 44240

Rev 7/25      10001C



EQ-48FC



LOT:







EXP:

Stop Use and Ask A Doctor If (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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain
  • nausea
  • vomiting
  • a sudden change in bowel habits over a period of 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)