Medi-first Pep-t-med

Medi-first Pep-t-med
SPL v10
SPL
SPL Set ID 88f4d5d4-92ed-40ab-97a9-181da72f869b
Route
ORAL
Published
Effective Date 2021-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: RH;046 Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-12-01

Description

Drug Facts


Medication Information

Warnings and Precautions

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 alert: Contains salicylate. Do not take if you are:

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

Indications and Usage

Uses

relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Dosage and Administration

Directions

  • chew or dissolve in mouth
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Adults and children: (12 years and over)

  • chew 2 tablets every 1/2 to 1 hour as needed
  • do not exceed 16 tablets in 24 hours
  • use until diarrhea stops, but not more than 2 days

Children under 12 years: Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of accidental overdose, contact a physician or poison control center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if

  • symptoms get worse or lasts for more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Section 50567-7

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

Section 50568-5

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

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3

Ask a doctor before use if you have

  • fever
  • mucus in the stool
Section 50570-1

Do not use if you have

  • bloody or black stool
  • an ulcer
  • a bleeding problem
Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments?

1-800-634-7680

Section 53414-9

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

Section 55105-1

Purpose

Upset stomach reliever/antidiarrheal

Section 55106-9

Active ingredient (in each tablet)

Bismuth Subsalicylate 262 mg

(each tablet contains 102 mg salicylate)

Section 60561-8

Other information

  • phenylketonurics: contains phenylalanine 1.1mg per tablet
  • calcium content per tablet: 73 mg
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Medi First Pep T Med Label

36 Chewable Tablets

Medi-First®

PEP-T-MED

Chewable Tablets

Compare active ingredients to:

Pepto Bismol®

Registered Trademark of Proctor & Gamble

Upset Stomach/Diarrhea Relief • Bismuth Subsalicylate 262mg

Chew or crush tablets completely before swallowing.

Do not swallow tablets whole.

Tamper Evident


Structured Label Content

Indications and Usage (34067-9)

Uses

relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
Dosage and Administration (34068-7)

Directions

  • chew or dissolve in mouth
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Adults and children: (12 years and over)

  • chew 2 tablets every 1/2 to 1 hour as needed
  • do not exceed 16 tablets in 24 hours
  • use until diarrhea stops, but not more than 2 days

Children under 12 years: Ask a doctor

Warnings and Precautions (34071-1)

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 alert: Contains salicylate. Do not take if you are:

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

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 physician or poison control center right away (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • symptoms get worse or lasts for more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • fever
  • mucus in the stool
Section 50570-1 (50570-1)

Do not use if you have

  • bloody or black stool
  • an ulcer
  • a bleeding problem
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions or comments?

1-800-634-7680

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Upset stomach reliever/antidiarrheal

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Bismuth Subsalicylate 262 mg

(each tablet contains 102 mg salicylate)

Section 60561-8 (60561-8)

Other information

  • phenylketonurics: contains phenylalanine 1.1mg per tablet
  • calcium content per tablet: 73 mg
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Medi First Pep T Med Label (Medi-First Pep-T-Med Label)

36 Chewable Tablets

Medi-First®

PEP-T-MED

Chewable Tablets

Compare active ingredients to:

Pepto Bismol®

Registered Trademark of Proctor & Gamble

Upset Stomach/Diarrhea Relief • Bismuth Subsalicylate 262mg

Chew or crush tablets completely before swallowing.

Do not swallow tablets whole.

Tamper Evident


Advanced Ingredient Data


Raw Label Data

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