ULTRA STRENGTH DIGESTIVE RELIEF- bismuth subsalicylate tablet

Ultra Strength digestive relief by

Drug Labeling and Warnings

Ultra Strength digestive relief by is a Otc medication manufactured, distributed, or labeled by THE KROGER CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Bismuth Subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

• ▪ travelers' diarrhea
• ▪ diarrhea
• ▪ upset stomach due to overindulgence in food and drink, including:
  • ▪ heartburn
  • ▪ indigestion
  • ▪ nausea
  • ▪ gas
  • ▪ belching
  • ▪ fullness

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 behavior 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

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

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 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 a doctor if

• ▪ symptoms get worse or last more than 2 days
• ▪ 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 right away.

Directions

• ▪ swallow with water, do not chew
• ▪ adults and children 12 years and over: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
• ▪ 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• ▪ do not exceed 8 doses (8 caplets) 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 54 mg
• ▪ salicylate 199 mg
• ▪ store at room temperature

Inactive ingredients

calcium carbonate, crospovidone, FD&C Red No. 27 Lake, magnesium stearate, microcrystalline cellulose, polysorbate 80.

Questions?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

NDC: 30142-138-24

Ultra Strength Digestive Relief

Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal

Symptom Digestive Relief

• Heartburn
• Indigestion
• Nausea
• Upset Stomach
• Diarrhea

24 Caplets

2X STRENGTH per caplet*

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH DIGESTIVE RELIEF 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-138
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL (Caplet)	Size	18mm
Flavor		Imprint Code	RP130
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-138-24	1 in 1 CARTON	11/18/2019
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	11/18/2019

Labeler - THE KROGER CO. (006999528)