PEPTO-BISMOL INSTACOOL- bismuth subsalicylate tablet, chewable 
Procter & Gamble Manufactura S de RL de CV

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.

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Pepto-BISMOL™



InstaCool ™

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

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

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not exceed 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 clear fluids to help prevent dehydration caused by diarrhea

Other information

  • each tablet contains: calcium 85 mg
  • sodium less than 1 mg
  • salicylate 100 mg
  • very low sodium
  • sugar free
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

calcium carbonate, flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, saccharin sodium, talc

Questions?

1-800-717-3786

Made in Mexico by Procter & Gamble
Manufactura S. de R. L. de C.V.
Dist. by Procter & Gamble, Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 30 Chewable Tablets

NEW

Pepto-
BISMOL™

InstaCool ™

PEPPERMINT

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

NDC 37000-691-30

5 SYMPTOM RELIEF
Nausea • Heartburn • Indigestion
Upset Stomach • Diarrhea

30 CHEWABLE TABLETS

PRINCIPAL DISPLAY PANEL - 30 Chewable Tablets
PEPTO-BISMOL  INSTACOOL
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-691
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
TALC (UNII: 7SEV7J4R1U)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POVIDONE (UNII: FZ989GH94E)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58933-691-241 in 1 CARTON07/09/2009
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:58933-691-301 in 1 CARTON07/09/2009
230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:58933-691-011 in 1 BOX07/09/2009
31000 in 1 BAG; Type 0: Not a Combination Product
4NDC:58933-691-022 in 1 BOX07/09/2009
46000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33507/09/200912/01/2021
Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)

Revised: 12/2019
Document Id: 99d751d0-4393-2249-e053-2995a90a183f
Set id: 69961b71-9090-5219-e053-2991aa0ad15d
Version: 2
Effective Time: 20191216
 
Procter & Gamble Manufactura S de RL de CV