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

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Topcare Stomach Relief

Topco Associates LLC

Topco Associates LLC. Stomach Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 1050 mg

Purpose

Upset stomach reliever and antidiarrheal

Topcare Stomach Relief 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
  • •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
  • •use dose cup
  • •adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every hour as needed
  • •do not exceed 4 doses (120 mL or 8 TBSP) 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

Topcare Stomach Relief Other information

  • •each 30 mL dose cup contains: magnesium 15 mg, potassium 5 mg and sodium 12 mg
  • •salicylate 461 mg
  • •low sodium
  • •protect from freezing
  • •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?

1-888-423-0139

Principal Display Panel

MAXIMUM STRENGTH

Stomach Relief

BISMUTH SUBSALICYLATE 1050 mg per 30 mL

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 Symptom Digestive Relief

Heartburn

Indigestion

Nausea

Upset Stomach

Diarrhea

COMPARE TO PEPTO-BISMOL® MAX STRENGTH active ingredient

8 FL OZ (237 mL)

Topcare Stomach Relief

Bismuth subsalicylate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-337
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
D&C RED NO. 22
D&C RED NO. 28
magnesium aluminum silicate
methyl salicylate
water
saccharin sodium
Salicylic Acid
SODIUM SALICYLATE
sorbic acid
XANTHAN GUM

Product Characteristics

Color
PINK (viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-337-34 237 in 1 BOTTLE
2 NDC:36800-337-40 355 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 1989-12-15


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