FDA.reportPublic FDA data

Rolaids ULTRA STRENGTH 1200

Manufacturer
THE PROCTER & GAMBLE MANUFACTURING COMPANY
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-06 02:02:20

Label at a glance#

ProductRolaids ULTRA STRENGTH 1200
Active ingredientCALCIUM CARBONATE, MAGNESIUM HYDROXIDE
Label structure12 sections

Indications and uses

for the relief of: heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Dosage and administration

adults and children 12 years and over: 2-3 chewable tablets as symptoms occur, or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each chewable tablet)
Calcium carbonate 1000 mg
Magnesium hydroxide 200 mg

Purposes

OTC - PURPOSE SECTION

Antacid

Antacid

Uses

INDICATIONS & USAGE SECTION

for the relief of:

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • now taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 7 tablets in a 24-hour period
  • do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: 2-3 chewable tablets as symptoms occur, or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each chewable tablet contains:
  • calcium 400 mg
  • magnesium 90 mg
  • store at room temperature 20º -25°C (68º - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, corn starch, dextrose, flavors, magnesium stearate, maltodextrin, silicon dioxide, sucralose, sucrose, water, xanthan gum, xylitol

Questions?

SPL UNCLASSIFIED SECTION

1-833-372-2729

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS MISSING OR DAMAGED

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALCIUM CARBONATE, MAGNESIUM HYDROXIDE • ANTACID

Rolaids

ULTRA STRENGTH

1200*

STRONG • FAST

HEARTBURN

RELIEF

*1200 mg Antacid per tablet

MINT FLAVORED

72 CHEWABLE TABLETS

325325

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130720112004535GTIN-13: 0720112004535
EAN-13: 0720112004535
GTIN-12: 720112004535
UPC-A: 720112004535
GTIN storage (14 digits): 00720112004535		325.jpg
Data codeData Matrix21455395325.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-32584126-325-10, 84126-325-72

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DEXTROSEIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
STARCH, CORNO8232NY3SJIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
XYLITOLVCQ006KQ1EIACT
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-02full-release2026-06-01 01:19:15

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rolaids ULTRA STRENGTH 1200CALCIUM CARBONATE, MAGNESIUM HYDROXIDETHE PROCTER & GAMBLE MANUFACTURING COMPANY28d9897d-46bf-d206-e063-6394a90a2b272025-12-02WarningsExact identifier
ndc (package): 84126-325-72
ndc (package): 84126-325-10
ndc (product): 84126-325
ndc11 (package): 84126032510
ndc11 (package): 84126032572
spl set id: 28d9897d-46bf-d206-e063-6394a90a2b27

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.