PEPT-ACHE

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In Each Tablet)

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

Purpose

Antidiarrheal/Antacid

Use

temporarily relieves:

• controls diarrhea
• relieves heartburn, indigestion, nausea and upset stomach without constipating

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 Warning

Contains salicylate. 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
• an ulcer
• a bleeding problem

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 a prescription drug for:

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

Stop use and ask a doctor if

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

OTC - WHEN USING SECTION

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

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. In case of accidental overdose, contact a doctor or Poison Control Center right away.

Directions

Children under 12 years: ask a doctor

• do not use more than directed
• chew or dissolve in mouth
• use until diarrhea stops but not more than 2 days
• drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
• do not exceed 16 tablets in 24 hours Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed

Other information

• phenylketonurics: contains phenylalanine 1.1mg per tablet
• each tablet contains 73mg elemental calcium
• store at room temperature 59º-86ºF (15º-30ºC)
• tamper-evident sealed packets do not use if packet is opened or torn

Inactive ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide

Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST