Mylanta
- Manufacturer
- Infirst Healthcare Inc.
- Effective date
- 2024-05-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:52
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
(in each 10 mL dose)
Calcium carbonate 800 mg
Simethicone Emulsion 266.6 mg/ Simethicone 80 mg
OTC - PURPOSE SECTION
Purposes
Antacid
Anti-gas
INDICATIONS & USAGE SECTION
Uses relieves:
• heartburn • acid indigestion • sour stomach
• upset stomach due to thse symptoms
• pressure and bloating commonly referred to as gas
• overindulgence in food and drink
WARNINGS SECTION
Warnings
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.
DOSAGE & ADMINISTRATION SECTION
Directions
• shake well before use • measure with dosing cup provided
• take as needed, between meals, at bedtime or as directed by a doctor
• do not use the maximum dosage for more than 2 weeks
• follow directions based on age below
| Age | Dosage |
| children ages 6-11 yrs | 10 mL. Not to exceed more than 30 mL in 24 hours |
| adults and children 12 yrs of age and over | 10-20 mL. Not to exceed more than 60 mL in 24 hours |
• mL=milliliter
Other information
• each 10 mL dose contains:
calcium 320 mg; sodium 5 mg
• store between 20-25°C (68-77°F), do not freeze
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzyl alcohol, carboxymethylcellulose sodium, D&C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum
OTC - QUESTIONS SECTION
Questions or comments? call 1-844-695-6624
toll free (English and Spanish)
SPL UNCLASSIFIED SECTION
Great-tasting
All-Family Mylanta ®
QUICKLY SOOTHES for fast relief
MULTI-SYMPTOM RELIEF
of heartburn, gas, and upset stomachs
due to overindulgence in food and drink
GREAT-TASTING mixed berry flavor
ACTIVE INGREDIENTS:
CALCIUM CARBONATE, SIMETHICONE
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
infirst + ™
Manufactured for:
Infirst Healthcare Inc.
Westport, CT 06880
2024 Infirst Healthcare Inc.
©Mylanta.com
Lot:
Exp:
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
VALUE SIZE
ALL-FAMILY
Mylanta ®
ANTACID+ANTI-GAS
MULTI-SYMPTOM
STOMACH REMEDY
Fast Relief of Heartburn,
Gas, and Upset Stomachs
for Adults & Children
Ages 6+
MIXED BERRY FLAVOR
16 FL OZ (473 mL)
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62372-520-16 | MylantaAll-Family Multi Symptom Stomach Remedy | 473 mL in 1 BOTTLE | LIQUID | 473 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Mylanta All-Family Multi Symptom Stomach Remedy
- calcium carbonate, simethicone
- BENZYL ALCOHOL
- XANTHAN GUM
- SODIUM CARBONATE
- CARBOXYMETHYLCELLULOSE CALCIUM
- D&C RED NO. 28
- CALCIUM CARBONATE
- CALCIUM CATION
- MICROCRYSTALLINE CELLULOSE
- WATER
- SORBITOL
- GLYCERIN
- SUCRALOSE
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62372-520 | 62372-520-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SODIUM CARBONATE | 45P3261C7T | IACT |
| CARBOXYMETHYLCELLULOSE CALCIUM | UTY7PDF93L | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| CALCIUM CARBONATE | H0G9379FGK | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mylanta All-Family Multi Symptom Stomach Remedy | CALCIUM CARBONATE, SIMETHICONE | Infirst Healthcare Inc. | 19118884-2016-e86e-e063-6294a90a370c | 2024-05-22 | Warnings | 62372-520-16 62372-520 62372052016 19118884-2017-e86e-e063-6294a90a370c 19118884-2016-e86e-e063-6294a90a370c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

