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5346 - Cardinal


Drug Facts

Active ingredient (in each caplet) Bismuth subsalicylate 262 mg


OTC - PURPOSE SECTION

Purpose Upset stomach reliever and antidiarrheal


Uses

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


WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

OTC - WHEN USING SECTION

When using this product a temporary but harmless darkening of the stool and/or tongue may occur.


OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Directions

adults and children 12 years and over:

children under 12 years: ask a doctor

  • swallow caplets with water, do not chew

Other information

  • each caplet contains: salicylate 102 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F)
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.


SPL UNCLASSIFIED SECTION

RETAIN THIS CARTON FOR FULL LABELING INFORMATION

WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

COMPARE TO PEPTO-BISMOL active ingredient*

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 Product of Mexico


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL