VALUHEALTH BY SPIRIT

Set ID
26bba88a-7db2-4cef-b6b9-03183ee85152
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:15

Key Label Information

Active Ingredients And Purpose

Active Ingredient ( in each tablet) Calcium Carbonete USP 500 mg

Purpose Antacid

Uses

Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Warnings

Warnings

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Directions And Dosage

Directions adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctordo not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other Label Information

Other information

each tablet contains: elemental calcium 200 mg store between 20-25° C (68-77°) contains FD&C Yello No. 5 (tartrazine) as a color additive

Inactive ingredients adipic acid, FD&C Blue No. 1 lake, FD&C Yellow 5 (tartrazine), FD&C Yellow 6, FD&C Red No. 40, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sugar

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

Products

NDC Codes

Ingredients

NameUNIIKind
ADIPIC ACID76A0JE0FKJIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SUCROSEC151H8M554IACT
CALCIUM CARBONATEH0G9379FGKACTIM

Complete SPL Sections

DRUG FACTS

SPL UNCLASSIFIED SECTION

Active Ingredient ( in each tablet) Calcium Carbonete USP 500 mg

OTC - ACTIVE INGREDIENT SECTION

Purpose Antacid

OTC - PURPOSE SECTION

Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms

INDICATIONS & USAGE SECTION

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - WHEN USING SECTION

do not take more than 14 tablets in 24 hours if pregnant do not take more than 10 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctordo not take for symptoms that persist for more than 2 weeks unless advised by a doctor

DOSAGE & ADMINISTRATION SECTION

Other information

STORAGE AND HANDLING SECTION

each tablet contains: elemental calcium 200 mg store between 20-25° C (68-77°) contains FD&C Yello No. 5 (tartrazine) as a color additive

Inactive ingredients adipic acid, FD&C Blue No. 1 lake, FD&C Yellow 5 (tartrazine), FD&C Yellow 6, FD&C Red No. 40, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sugar

INACTIVE INGREDIENT SECTION

Questions or comments? 1-888-333-9792

OTC - QUESTIONS SECTION

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
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XML bytes
19525

Legacy File Index

FolderFileDate
otc2900d36e-bf7a-475f-e063-6294a90a1d0f.xml2024-12-13
otc0c7cd738-6774-c3f5-e063-6394a90aee5c.xml2023-12-15
otcLabel.jpg2023-12-15