Pept-ache

Pept-ache
SPL v2
SPL
SPL Set ID 894c1912-cd24-4ddf-b7e7-dae9dd64b280
Route
ORAL
Published
Effective Date 2024-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Acacia Aspartame Calcium Carbonate D&c Red No. 27 Dextrates Magnesium Stearate Maltodextrin Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RH046 Shape: round Color: pink Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-02-02

Description

Drug Facts

Purpose

Antidiarrheal/Antacid


Medication Information

Purpose

Antidiarrheal/Antacid

Description

Drug Facts

Use

temporarily relieves:

  • controls diarrhea
  • relieves heartburn, indigestion, nausea and upset stomach without constipating
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

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

Section 50568-5

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

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis
Section 53414-9

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

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

Questions?

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

Allergy Warning

Contains salicylate. Do not take if you are:

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

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

Do Not Use If You Have
  • bloody or black stool
  • an ulcer
  • a bleeding problem
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
Active Ingredient (in Each Tablet)

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

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
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


Structured Label Content

Use

temporarily relieves:

  • controls diarrhea
  • relieves heartburn, indigestion, nausea and upset stomach without constipating
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis
Section 53414-9 (53414-9)

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

Purpose

Antidiarrheal/Antacid

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

Questions?

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

Allergy Warning

Contains salicylate. Do not take if you are:

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

Other Information (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 (Inactive ingredients)

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

Do Not Use If You Have (Do not use if you have)
  • bloody or black stool
  • an ulcer
  • a bleeding problem
Stop Use and Ask A Doctor If (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
Active Ingredient (in Each Tablet) (Active ingredient (In Each Tablet))

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Principal Display Panel 36 Tablet Packet Box (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


Advanced Ingredient Data


Raw Label Data

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