PEPTO BISMOL FAST MELTS WINTER FROST FLAVORED- bismuth subsalicylate tablet, chewable

Pepto Bismol Fast Melts by

Drug Labeling and Warnings

Pepto Bismol Fast Melts 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 soft 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

PREGNANCY OR BREAST FEEDING

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 soft chewable tablets every 1/2 hour or 4 soft chewable tablets every hour as needed for diarrhea

     2 soft chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

• do not exceed 8 doses (16 soft 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 soft chewable tablet contains:   calcium 55 mg   salicylate 100 mg   low sodium
• Store at no greater than 25°C.  Avoid excessive heat (over 40°C).

Inactive ingredients

calcium carbonate, carrageenan, corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavor, hydrogenated coconut oil, soy lecithin, sucrose, water

Questions?

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF INNER PRINTED SEAL ON BOTTLE IS BROKEN OR MISSING.

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 24 SOFT CHEWABLE TABLETS

Pepto Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

FAST MELTS

COATS & COOLS

WINTER FROST FLAVORED

24 SOFT CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

PEPTO BISMOL FAST MELTS  WINTER FROST FLAVORED
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-832
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	22mm
Flavor	MINT	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-832-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	03/05/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)