FDA.reportPublic FDA data

Rolaids

Manufacturer
THE PROCTER & GAMBLE MANUFACTURING COMPANY
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-06 02:03:02

Label at a glance#

ProductRolaids Ultra Strength Antacid Strawberry
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 soft 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 soft chewable tablet)
Calcium carbonate USP 1330 mg
Magnesium Hydroxide USP 235 mg

Purpose

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 or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not take more than 5 soft chewable 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 breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 soft chewable tablets as symptoms occur, or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each soft chewable tablet contains: calcium 615 mg, magnesium 110 mg
  • store at room temperature 20°-25°C (68°-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, corn syrup, FD&C Red No 40 aluminum lake, flavors, glycerin, hydrogenated coconut oil, lecithin (soy), sucrose, water

Questions?

SPL UNCLASSIFIED SECTION

1-833-372-2729

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF FOIL WRAPPING IS DAMAGED.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rolaids

ULTRA STRENGTH

SOFT CHEWS

CALCIUM CARBONATE

MAGNESIUM HYDROXIDE

ANTACID

individually wrapped

STRAWBERRY FLAVORED

6 SOFT CHEWABLE TABLETS

829829

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130720112004672GTIN-13: 0720112004672
EAN-13: 0720112004672
GTIN-12: 720112004672
UPC-A: 720112004672
GTIN storage (14 digits): 00720112004672		829.jpg
Data codeData Matrix21073075829.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-82969423-829-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIM
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-10-03full-release2026-06-01 01:15:43

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 Antacid StrawberryCALCIUM CARBONATE, MAGNESIUM HYDROXIDETHE PROCTER & GAMBLE MANUFACTURING COMPANY0f8d39d7-173b-7750-e063-6394a90ade822025-10-03WarningsExact identifier
ndc (package): 69423-829-06
ndc (product): 69423-829
ndc11 (package): 69423082906
spl set id: 0f8d39d7-173b-7750-e063-6394a90ade82

Reported adverse events (FAERS/openFDA)#

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