FDA.reportPublic FDA data

Mylanta Fall Harvest Collection Pumpkin Spice

Manufacturer
Infirst Healthcare Inc.
Effective date
2026-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-08 02:02:12

Label at a glance#

ProductMylanta Fall Harvest Collection Pumpkin Spice
Active ingredientCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure10 sections

Indications and uses

relieves: heartburn pressure and bloating commonly referred to as gas acid indigestion sour stomach upset stomach due to these symptoms overindulgence in food and drink

Dosage and administration

shake well before use measure with dosing cup provided adults and children 12 years and over : 10 mL-20 mL (1-2 doses) between meals, at bedtime or as directed by a doctor do not take more than 60 mL (6 doses) in any 24- hour period do not use the maximum dosage for more than 2 weeks children under 12 years : ask a doctor mL= milliliter

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

Active ingredients (in each 10 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 800 mg

Magnesium hydroxide 270 mg
Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid
Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves:

  • heartburn
  • pressure and bloating commonly referred to as gas
  • acid indigestion
  • sour stomach
  • upset stomach due to these symptoms
  • overindulgence in food and drink

Warnings

WARNINGS SECTION

Ask a doctor before use if you have
• kidney disease • a magnesium restricted diet

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

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help
or contact a poison control center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • measure with dosing cup provided
  • adults and children 12 years and over: 10 mL-20 mL (1-2 doses) between meals, at bedtime or as directed by a doctor
  • do not take more than 60 mL (6 doses) in any 24- hour period
  • do not use the maximum dosage for more than 2 weeks
  • children under 12 years: ask a doctor
  • mL= milliliter

Other information

SPL UNCLASSIFIED SECTION

•each 10 mL dose contains:

calcium 320 mg; magnesium 115mg; sodium 7 mg

• store between 20-25°C (68-77°F), do not freeze.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call 1-844-695-6624toll free (English and Spanish)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MYLANTA ®

FALL HARVEST COLLECTION

LIQUID

ANTACID + ANTI-GAS

WORKS ON CONTACT

Fast relief of heartburn, acid indigestin, and painful gas.

PUMPKIN SPICE FLAVOR

12 FL OZ (355mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Mylanta ® is a registered trademark used under license.

infirst +

HEALTHCARE ®

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2025 Infirst Healthcare Inc.

Mylanta.com

labellabel

back labelback label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130819903011040GTIN-13: 0819903011040
EAN-13: 0819903011040
GTIN-12: 819903011040
UPC-A: 819903011040
GTIN storage (14 digits): 00819903011040		Pumpkin back.jpg

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62372-54262372-542-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB
BENZYL ALCOHOLLKG8494WBHIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
WATER059QF0KO0RIACT
SODIUM CARBONATE45P3261C7TIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
ndc (package): 62372-542-12
ndc (product): 62372-542
ndc11 (package): 62372054212
spl id: 5a60a22f-f5ac-881f-e063-6294a90afe56
spl set id: 5a60a221-5b37-806e-e063-6394a90a5ccc

Reported adverse events (FAERS/openFDA)#

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