Leader Stomach Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Leader Stomach Relief

Cardinal Health

Cardinal Health Stomach Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 15 mL Tablespoon)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever/antidiarrheal

Leader Stomach Relief Uses

relieves

  • •travelers’ diarrhea
  • •diarrhea
  • •upset stomach due to overindulgence in food and drink, including:
  • •heartburn
  • •indigestion
  • •nausea
  • •gas
  • •belching

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

  • •diarrhea lasts more than 2 days
  • •symptoms get worse
  • •ringing in the ears or loss of hearing occurs

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. (1-800-222-1222)

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 1/2 to 1 hour as needed
  • •do not exceed 8 doses (16 Tbsp or 240 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

Leader Stomach Relief Other information

  • •each Tbsp contains: magnesium 5 mg, potassium 5 mg and sodium 6 mg
  • •salicylate 127 mg
  • •low sodium
  • •sugar free
  • •store at 20-25°C (68-77°F)
  • •does not meet USP requirements for pH
  • •for health information visit www.more-info.info

Inactive ingredients

D&C red #22, D&C red #28, magnesium aluminum silicate, methyl salicylate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Original Pepto-Bismol® active ingredient

ORIGINAL STRENGTH

Stomach Relief

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever/Antidiarrheal

5 Symptom Relief of:

Heartburn – Indigestion – Upset Stomach – Nausea – Diarrhea

12 FL OZ (355 mL)

Leader Stomach Relief

Bismuth subsalicylate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49781-025
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bismuth Subsalicylate BISMUTH CATION 262 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 22
D&C RED NO. 28
magnesium aluminum silicate
water
saccharin sodium
Salicylic Acid
SODIUM SALICYLATE
sorbic acid
XANTHAN GUM
methyl salicylate

Product Characteristics

Color
PINK (viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49781-025-12 355 in 1 BOTTLE
2 NDC:49781-025-08 237 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 1990-04-15


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Be sure to consult your doctor before taking any medication!
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