Indications and uses
relieves: • heartburn • acid indigestion • sour stomach • upset stomach due to these symptoms • pressure and bloating commonly referred to as gas • overindulgence in food and drink
Mylanta Vanilla Caramel
- Manufacturer
- Infirst Healthcare Inc.
- Effective date
- 2024-02-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:20
Label at a glance#
ProductMylanta Vanilla Caramel
Active ingredientCALCIUM CARBONATE, DIMETHICONE, MAGNESIUM HYDROXIDE
Label structure10 sections
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) as needed, 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Calcium carbonate 800 mg
Magnesium hydroxide 270 mg
Simethicone 80 mg
Purposes
Antacid
Antacid
Anti-gas
Uses
relieves:
• heartburn • acid indigestion • sour stomach
• upset stomach due to these symptoms
• pressure and bloating commonly referred to as gas
• overindulgence in food and drink
Warnings
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
• kidney disease • a magnesium restricted diet
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.
Directions
• shake well before use • measure with dosing cup provided
• adults and children 12 years and over:
10 mL-20 mL (1-2 doses) as needed, 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
each 10 mL dose contains:
calcium 335 mg; magnesium 120 mg; sodium 8 mg
• store between 20-25°C (68-77°F), do not freeze
Inactive ingredients
benzoic acid, benzyl alcohol, edetate disodium, flavor, glycerin, glyceryl monostearate, methylcellulose, microcrystalline cellulose, peg-8 stearate, polysorbate 65, purified water, sodium benzoate, sorbic acid, sucralose, xanthan gum
Questions or comments?
call 1-844-695-6624 toll free (English and Spanish)
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
infirst +
HEALTHCARE®
Manufactured for:
Infirst Healthcare Inc.
Westport, CT 06880
©2023 Infirst Healthcare Inc.
Mylanta.com
Lot:
Exp:
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Mylanta ®
LIQUID ANTACID+ANTI-GAS
WORKS ON CONTACT!
Fast relief of heartburn, acid indigestion, and painful gas.
VANILLA CARAMEL FLAVOR
12 FL OZ (355 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1788932 | calcium carbonate 800 MG / magnesium hydroxide 270 MG / simethicone 80 MG in 10 mL Oral Suspension | PSN | 1 |
| 1788932 | calcium carbonate 80 MG/ML / magnesium hydroxide 27 MG/ML / simethicone 8 MG/ML Oral Suspension | SCD | 1 |
| 1788932 | calcium carbonate 800 MG / magnesium hydroxide 270 MG / simethicone 80 MG per 10 ML Oral Suspension | SY | 1 |
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 |
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62372-541-12 | Mylanta Vanilla Caramel | 355 mL in 1 BOTTLE | LIQUID | 355 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Mylanta Vanilla Caramel
- Calcium carbonate, magnesium hydroxide, simethicone
- BENZYL ALCOHOL
- XANTHAN GUM
- GLYCERIN
- GLYCERYL MONOSTEARATE
- MICROCRYSTALLINE CELLULOSE
- CALCIUM CARBONATE
- CALCIUM CATION
- DIMETHICONE
- METHYLCELLULOSE, UNSPECIFIED
- PEG-8 STEARATE
- SODIUM BENZOATE
- SORBIC ACID
- SUCRALOSE
- MAGNESIUM HYDROXIDE
- MAGNESIUM CATION
- POLYSORBATE 65
- EDETATE DISODIUM
- WATER
- BENZOIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62372-541 | 62372-541-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 Vanilla Caramel | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE | Infirst Healthcare Inc. | 10a66d74-74b4-3f8d-e063-6394a90a7f00 | 2024-02-05 | Warnings | 62372-541-12 62372-541 62372054112 10a66d74-74b5-3f8d-e063-6394a90a7f00 10a66d74-74b4-3f8d-e063-6394a90a7f00 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.