MYLANTA ALL-FAMILY MULTI SYMPTOM STOMACH REMEDY- calcium carbonate, simethicone liquid

Mylanta by

Drug Labeling and Warnings

Mylanta by is a Otc medication manufactured, distributed, or labeled by Infirst Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 10 mL dose)

Calcium carbonate 800 mg

Simethicone Emulsion 266.6 mg/ Simethicone 80 mg

PURPOSE

Purposes

Antacid

Anti-gas

INDICATIONS & USAGE

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

Warnings

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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

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

Inactive ingredients

benzyl alcohol, carboxymethylcellulose sodium, D&C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

QUESTIONS

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:

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)

INGREDIENTS AND APPEARANCE

MYLANTA  ALL-FAMILY MULTI SYMPTOM STOMACH REMEDY
calcium carbonate, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-520
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CARBONATE (UNII: 45P3261C7T)
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BERRY (Mixed)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-520-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	05/21/2024

Labeler - Infirst Healthcare Inc. (079159739)