PEPT-ACHE- bismuth subsalicylate tablet, chewable

PEPT-ACHE by

Drug Labeling and Warnings

PEPT-ACHE by is a Otc medication manufactured, distributed, or labeled by JHK Inc dba American Safety & First Aid. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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

Directions

• 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

Children under 12 years: ask a doctor

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

PRINCIPAL DISPLAY PANEL - 36 Tablet Packet Box

This product is not manufactured or distributed by Proctor & Gamble
Owner of the registered trademark Pepto-Bismol®.

Pept-Ache

Anti-Diarrheal

• Temporary relief from upset stomach
• Soothes nausea, heartburn and
  indigestion
• Chewable tablets

These quality comfort tablets are formulated and packaged for use in
the workplace and meet ANSI Z308. 1-2015 standards. They are
sealed in tamper-evident packets for safety and convenience.

36 Tablets 1 Tablet Per Packet

INGREDIENTS AND APPEARANCE

PEPT-ACHE 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-1232
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	RH046
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73598-1232-1	36 in 1 BOX	02/02/2000
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	02/02/2000

Labeler - JHK Inc dba American Safety & First Aid (867236309)