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careone stomach relief

American Sales Company

American Sales Company Stomach Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 15 mL Tablespoon)

Bismuth subsalicylate 525 mg

Purposes

Upset stomach reliever and antidiarrheal

careone 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

  • •symptoms get worse
  • •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. (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 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

careone stomach relief Other information

  • •each Tbsp contains: magnesium 5 mg, potassium 5 mg and sodium 6 mg
  • •salicylate 231 mg
  • •low sodium
  • •sugar free
  • •protect from freezing
  • •store at 20-25°C (68-77°)
  • •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 the Active Ingredient in Pepto-Bismol®

MAXIMUM STRENGTH

STOMACH RELIEF

Bismuth Subsalicylate 525 mg

Upset Stomach Reliever/Antidiarrheal

PROTECTIVE COATING ACTION

5 Symptom Relief of:

Nausea, Heartburn, Indigestion

Upset Stomach, Diarrhea

12 FL OZ (355 mL)

careone stomach relief

Bismuth subsalicylate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-337
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bismuth Subsalicylate BISMUTH CATION 525 mg

Inactive Ingredients

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

Product Characteristics

Color
PINK (viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-337-34 237 in 1 BOTTLE
2 NDC:41520-337-40 355 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 2012-08-05


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Be sure to consult your doctor before taking any medication!
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