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Pepto Relief

Advance Pharmaceutical Inc.
Advance Pharmaceutical Inc.

PEPTO RELIEF Bismuth Subsalicylate 262 MG




FULL PRESCRIBING INFORMATION

.

(in each tablet)

Bismuth subsalicylate 262 mg

Anti-diarrheal/Upset stomach reliever

  • Controls diarrhea
  • Relieves upset stomach due to overindulgence in food or drink

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: Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

    Do not use

  • If you have bloody or black stool
  • If you have an ulcer or bleeding problem

    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.

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor
  • Each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

Pepto ReliefPepto Relief

NDC: 17714-045-30  – 30 CHEWABLE TABLETS

Pepto Relief

Bismuth subsalicylate TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:17714-045
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
CALCIUM CARBONATE
D&C RED NO. 27
DEXTROSE
CHERRY
MAGNESIUM STEARATE
maltodextrin
SILICON DIOXIDE
sorbitol

Product Characteristics

Color Size Imprint Code Shape
PINK (light) 16 mm AP;045 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17714-045-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 2002-01-09


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Be sure to consult your doctor before taking any medication!
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