First Aid Direct Peptum Tabs — v13

First Aid Direct Peptum Tabs

8 Views

Version

v13

Effective date

September 29, 2025

Original packager

Yes

Sections captured

17

Identifiers

Document ID
504ab819-fdd1-42f0-92af-cf0cc25857a0
Set ID
dd14cd57-3f7c-4634-9da9-6f83dc5bae12
Application numbers
M008
Product NDCs
42961-109
Package NDCs
42961-109-01, 42961-109-02
Original packager NDCs
—

Names & Manufacturers

Brand names
First Aid Direct Peptum Tabs
Generic names
BISMUTH SUBSALICYLATE
Manufacturer names
Cintas Corp
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
BISMUTH SUBSALICYLATE
Routes
ORAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
Bismuth [EPC]
Pharmacologic class (CS)
Bismuth [CS]
Mechanism of action
—

Other identifiers

NUI
M0002611, N0000180183
RxCUI
—
UNII
62TEY51RR1
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Bismuth subsalicylate 262 mg (each tablet contains 102mg salicylate)
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have ​​fever mucus in stool
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are ​taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis
Do Not Use (1)

Sequence 1

Do not use if you have an ulcer a bleeding problem bloody or black stool
Dosage And Administration (1)

Sequence 1

Directions chew or dissolve in mouth Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) in 24 hours use until diarrhea stops but not more than 2 days Children under 12 : ask a doctor drink plenty of fluids to help prevent dehydration which may accompany diarrhea
Inactive Ingredient (1)

Sequence 1

Inactive ingredients acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
Indications And Usage (1)

Sequence 1

Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink including: heartburn indigestion nausea gas belching fullness
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. ​In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other Safety Information (1)

Sequence 1

Other information Phenylketonurics : contains phenylalanine 1.1 mg per tablet Calcium content per tablet: 73mg store at room temperature 15° - 30°C (59° - 86°F) avoid excessive heat (over 40°C or 104°F) do not use if cellophane unit is torn
Package Label Principal Display Panel (1)

Sequence 1

Principal Display Panel - Box Pep Tum ​™ Bismuth subsalicylate COMPARE ACTIVE INGREDIENTS TO PEPTO-BISMOL ®* 262 mg SOOTHING RELIEF FOR: Upset Stomach Diarrhea Heartburn Indigestion Nausea 30 Chewable Tablets Box
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ​ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Antidiarrheal/Antacid
Questions (1)

Sequence 1

Questions? 1-800-327-2704 Monday-Friday 8:00am - 5:00pm (CDT)
Spl Product Data Elements (1)

Sequence 1

First Aid Direct Peptum Tabs Bismuth Subsalicylate BISMUTH SUBSALICYLATE SALICYLIC ACID ACACIA ASPARTAME CALCIUM CARBONATE D&C RED NO. 27 ALUMINUM LAKE DEXTRATES MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE PEPPERMINT SILICON DIOXIDE RH046
Stop Use (1)

Sequence 1

Stop use and ask a doctor if ​symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days
Warnings (1)

Sequence 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 occurs, 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 salicylate (including asprin) taking other salicylate products Do not use if you have an ulcer a bleeding problem bloody or black stool Ask a doctor before use if you have ​​fever mucus in stool Ask a doctor or pharmacist before use if you are ​taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis When using this product ​a temporary, but harmless darkening of the stool and/or tongue may occur Stop use and ask a doctor if ​symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast-feeding, ​ask a health professional before use. Keep out of reach of children. ​In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M008'],
 'brand_name': ['First Aid Direct Peptum Tabs'],
 'generic_name': ['BISMUTH SUBSALICYLATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cintas Corp'],
 'nui': ['M0002611', 'N0000180183'],
 'package_ndc': ['42961-109-01', '42961-109-02'],
 'pharm_class_cs': ['Bismuth [CS]'],
 'pharm_class_epc': ['Bismuth [EPC]'],
 'product_ndc': ['42961-109'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['504ab819-fdd1-42f0-92af-cf0cc25857a0'],
 'spl_set_id': ['dd14cd57-3f7c-4634-9da9-6f83dc5bae12'],
 'substance_name': ['BISMUTH SUBSALICYLATE'],
 'unii': ['62TEY51RR1']}