Pepto-Bismol description, usages, side effects, indications, overdosage, supplying and lots more!

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Pepto-Bismol

Procter & Gamble Manufacturing Company

Pepto-Bismol™ Max Strength


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 15 ml Tablespoon)

Bismuth subsalicylate 525 mg

Purposes

Upset stomach reliever and antidiarrheal

Pepto-Bismol Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach
  • heartburn
  • indigestion
  • nausea

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

  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (2 Tbsp or 30 ml) every hour as needed
  • do not exceed 4 doses (8 Tbsp or 120 ml) 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

Pepto-Bismol Other information

  • each Tbsp contains: sodium 6 mg
  • salicylate 236 mg
  • low sodium
  • sugar free
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

benzoic acid, flavor, magnesium aluminum silicate, methylcellulose, red 22, red 28, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, water

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 37000-019-01

Pepto∙
BISMOL™
MAX
STRENGTH

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

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

4 FL OZ (118 mL)

Pepto-Bismol

Pepto-Bismol

Bismuth subsalicylate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37000-019
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bismuth Subsalicylate BISMUTH CATION 1050 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
magnesium aluminum silicate
D&C RED NO. 22
D&C RED NO. 28
SACCHARIN SODIUM DIHYDRATE
Salicylic Acid
SODIUM SALICYLATE
sorbic acid
water

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37000-019-01 118 in 1 BOTTLE, PLASTIC
2 NDC:37000-019-02 236 in 1 BOTTLE, PLASTIC
3 NDC:37000-019-03 354 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 1989-03-31


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Be sure to consult your doctor before taking any medication!
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