Equaline Stomach Relief Caplets 172

Equaline Stomach Relief Caplets 172
SPL v1
SPL
SPL Set ID a5767e55-97cc-4fe4-a431-668635e205af
Route
ORAL
Published
Effective Date 2024-05-13
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Calcium Carbonate D&c Red No. 27 Magnesium Stearate Mannitol Silicon Dioxide Microcrystalline Cellulose Polysorbate 80 Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: G;172 Shape: capsule Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-12

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 262 mg

Use(s)

relieves:



  • indigestion
  • nausea
  • heartburn
  • diarrhea
  • upset stomach associated with these symptoms
Warnings


Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness.



Allergy alert: Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Directions
  • swallow caplet(s) with water, do not chew
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days 
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information
  • each caplet contains:
  • calcium 27 mg, salicylate 102 mg and sodium 2 mg
  • very low sodium
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing 
  • store at room temperature, in a dry place
Inactive Ingredients

calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

Do Not Use If You Have
  • bloody or black stool
  • an ulcer
  • a bleeding problem
Principal Display Panel

EQUALINE

Compare to Pepto-Bismol®  active ingredient*

NDC 41163-123-28



Stomach Relief

bismuth subsalicylate 262 mg

anti-diarrheal/upset stomach reliever



relieves:

  • heartburn
  • nausea
  • Upset stomach
  • Indigestion
  • Diarrhea


40 CAPLETS   

 







When Using This Product

a temporary, but harmless darkening of the stool and/or tongue may occur

Stop Use and Ask Doctor If
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient(in Each Caplet)

Bismuth subsalicylate 262 mg





Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for 



  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Use(s) (USE(S))

relieves:



  • indigestion
  • nausea
  • heartburn
  • diarrhea
  • upset stomach associated with these symptoms
Purpose (PURPOSE)

Upset stomach reliever and anti-diarrheal

Warnings (WARNINGS)


Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness.



Allergy alert: Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Directions (DIRECTIONS)
  • swallow caplet(s) with water, do not chew
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days 
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information (OTHER INFORMATION)
  • each caplet contains:
  • calcium 27 mg, salicylate 102 mg and sodium 2 mg
  • very low sodium
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing 
  • store at room temperature, in a dry place
Inactive Ingredients (INACTIVE INGREDIENTS)

calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

Do Not Use If You Have (DO NOT USE IF YOU HAVE)
  • bloody or black stool
  • an ulcer
  • a bleeding problem
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

EQUALINE

Compare to Pepto-Bismol®  active ingredient*

NDC 41163-123-28



Stomach Relief

bismuth subsalicylate 262 mg

anti-diarrheal/upset stomach reliever



relieves:

  • heartburn
  • nausea
  • Upset stomach
  • Indigestion
  • Diarrhea


40 CAPLETS   

 







When Using This Product (WHEN USING THIS PRODUCT)

a temporary, but harmless darkening of the stool and/or tongue may occur

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
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.

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

Active Ingredient(in Each Caplet) (ACTIVE INGREDIENT(in each caplet))

Bismuth subsalicylate 262 mg





Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

taking any drug for 



  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)