Healthmart Stomach Relief: Package Insert and Label Information

HEALTHMART STOMACH RELIEF — bismuth subsalicylate tablet, chewable
Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT(in each tablet)

Bismuth subsalicylate 262 mg

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:

• diarrhea
• heartburn
• indigestion
• nausea
• 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

DO NOT USE IF YOU HAVE

• bloody or black stool
• an ulcer
• a bleeding problem

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

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

IF PREGNANT OR BREAST-FEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center immediately 1-800-222-1222.

DIRECTIONS

• chew or dissolve in mouth
• 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 fluids to help prevent dehydration caused diarrhea

OTHER INFORMATION

• each tablet contains:
• sodium less than 1 mg
• salicylate 102 mg
• very low sodium
• avoid excessive heat (over 104^o F or 40^o C)
• TAMPER EVIDENT: Do not use if individual compartments are torn on open.

INACTIVE INGREDIENTS

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

NDC 62011-0481-1
HealthMart
Compare to Pepto-Bismol^® Chewable Tablets Active Ingredient*
Regular Strength

Stomach Relief
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever / Anti-diarrheal
Soothing Relief for:

Upset stomach

Nausea, Heartburn

Indigestion & Diarrhea

30 Chewable Tablets

HEALTHMART STOMACH RELIEF bismuth subsalicylate tablet, chewable

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0481 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE D&C RED NO. 27 MAGNESIUM STEARATE MANNITOL STARCH, CORN SACCHARIN SODIUM

Product Characteristics Color PINK Score no score Shape ROUND Size 16mm Flavor Imprint Code G122 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62011-0481-1 5 BLISTER PACK in 1 BOX contains a BLISTER PACK 1 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the BOX (62011-0481-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 09/08/2021

Labeler — Strategic Sourcing Services LLC (116956644)

Revised: 09/2021 Strategic Sourcing Services LLC