PEPTO-BISMOL ULTRA- bismuth subsalicylate tablet

Pepto-Bismol by

Drug Labeling and Warnings

Pepto-Bismol by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufactura, S. de R.L. de C.V.. 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
• very low sodium
• avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

Questions?

1-800-717-3786

www.pepto-bismol.com

SPL UNCLASSIFIED SECTION

MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Caplet Carton

NEW

Pepto
Bismol ® ULTRA

Bismuth Subsalicylate
Upset Stomach Reliever/
Antidiarrheal

2x STRENGTH

per caplet*

5 SYMPTOM RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 CAPLETS

INGREDIENTS AND APPEARANCE

PEPTO-BISMOL  ULTRA
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58933-478
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
D&C RED NO. 27 (UNII: 2LRS185U6K)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58933-478-24	1 in 1 CARTON	02/01/2018
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58933-478-12	1 in 1 CARTON	02/01/2018
2		12 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	02/01/2018

Labeler - Procter & Gamble Manufactura, S. de R.L. de C.V. (812807550)