Xpect Antacid — v6

Xpect Antacid

4 Views

Version

v6

Effective date

September 22, 2025

Original packager

Yes

Sections captured

10

Identifiers

Document ID
a4f76e56-57be-4096-b14b-70e00581c581
Set ID
3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c
Application numbers
M001
Product NDCs
42961-208
Package NDCs
42961-208-04, 42961-208-05, 42961-208-06, 42961-208-07
Original packager NDCs

Names & Manufacturers

Brand names
Xpect Antacid
Generic names
CALCIUM CARBONATE
Manufacturer names
Cintas Corporation
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
CALCIUM CARBONATE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
308907
UNII
H0G9379FGK
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Calcium carbonate USP 500mg
Dosage And Administration (1)

Sequence 1

Directions chew 2-4 tablets as symptoms occur, repeat hourly if needed
Inactive Ingredient (1)

Sequence 1

Inactive ingredients FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, orange flavor, sorbitol
Indications And Usage (1)

Sequence 1

Uses relieves heartburn sour stomach acid indigestion upset stomach associated with these symptoms
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Package Label Principal Display Panel (2)

Sequence 1

Principal Display Panel - 100 count Box Compare active ingredient to Tums®* FRUIT FLAVORED ANTACID Active Ingredient: Calcium Carbonate 500 mg Antacid Relieves upset stomach, acid indigestion and heartburn Sugar-free, sodium-free formula Xpect® First aid WORKPLACE READY™ Single Dose Tamper Evident 100 Tablets • 50 Packets (2 Tablets in each Packet) per Box 115189 Distributed by: CINTAS® • Mason, OH 45040 • www.cintas.com Box100

Sequence 2

Principal Display Panel - 250 count Box Compare active ingredient to Tums®* FRUIT FLAVORED ANTACID Active Ingredient: Calcium Carbonate 500 mg Antacid Relieves upset stomach, acid indigestion and heartburn Sugar-free, sodium-free formula Xpect® First aid WORKPLACE READY™ Single Dose Tamper Evident 250 Tablets • 125 Packets (2 Tablets in each Packet) per Box 115199 Distributed by: CINTAS® • Mason, OH 45040 • www.cintas.com Box250
Purpose (1)

Sequence 1

Purpose Antacid
Spl Product Data Elements (1)

Sequence 1

Xpect Antacid Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION FD&C YELLOW NO. 6 MAGNESIUM STEARATE SORBITOL MALTODEXTRIN
Storage And Handling (1)

Sequence 1

Other information store at 15°-30°C (59°-86°F) do not use if packet is open or torn Calcium content per tablets: 200 mg
Warnings (1)

Sequence 1

Warnings Ask a doctor before use if you have kidney disease taking any prescription drugs; antacids may interact with certain precription drugs When using this product do not take more than 15 tablets in a 24 hour period or use the maximum dosage of this product for more than 2 weeks.

OpenFDA raw payload

{'application_number': ['M001'],
 'brand_name': ['Xpect Antacid'],
 'generic_name': ['CALCIUM CARBONATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cintas Corporation'],
 'package_ndc': ['42961-208-04',
                 '42961-208-05',
                 '42961-208-06',
                 '42961-208-07'],
 'product_ndc': ['42961-208'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['308907'],
 'spl_id': ['a4f76e56-57be-4096-b14b-70e00581c581'],
 'spl_set_id': ['3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c'],
 'substance_name': ['CALCIUM CARBONATE'],
 'unii': ['H0G9379FGK']}