PEPTO BISMOL CHEWS- bismuth subsalicylate tablet, chewable

Pepto Bismol by

Drug Labeling and Warnings

Pepto Bismol by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

Bismuth subsalicylate 262 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

Keep out of reach of children.

OVERDOSAGE

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

Directions

• fully chew before swallowing
• adults and children 12 years and over:
• 2 chewable tablets every ½ hour or 4 chewable tablets every hour as needed for diarrhea
• 2 chewable tablets every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 8 doses (16 chewable 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 chewable tablet contains:
• calcium 50 mg salicylate 117 mg
• low sodium
• Store at no greater than 25°C. Avoid excessive heat (over 40°C.)

Inactive ingredients

acacia, anhydrous citric acid, calcium carbonate, caprylic/capric triglyceride, carmine, carnauba wax, corn starch, corn syrup, dextrin, FD&C Blue No. 2 Aluminum Lake, flavors, hydrogenated coconut oil, maltodextrin, potassium hydroxide, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, water, white wax

Questions?

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 Chewable Tablets

Pepto Bismol ®

Bismuth Subsalicylate -

Upset Stomach Reliever/ Antidiarrheal

CHEWS

BERRY MINT FLAVORED

24 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

PEPTO BISMOL  CHEWS
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-963
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
ICODEXTRIN (UNII: 2NX48Z0A9G)
ACACIA (UNII: 5C5403N26O)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STARCH, CORN (UNII: O8232NY3SJ)
CORN SYRUP (UNII: 9G5L16BK6N)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCROSE (UNII: C151H8M554)
CARMINIC ACID (UNII: CID8Z8N95N)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	18mm
Flavor	WINTERGREEN	Imprint Code	PB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-963-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2020
2	NDC: 69423-963-72	72 in 1 CELLO PACK	09/01/2020
2		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	09/01/2020

Labeler - The Procter & Gamble Manufacturing Company (004238200)