MYLANTA NEW TONIGHT SOOTHING HONEY CHAMOMILE- calcium carbonate,magnesium hydroxide and simethicone suspension

Mylanta New Tonight Soothing Honey Chamomile by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each 10 mL dose)

Calcium carbonate 800 mg

Magnesium hydroxide 270 mg
Simethicone 80 mg

Purpose

Antacid

Antacid
Anti-gas

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

Warnings

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

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.

Directions

•   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

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

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

Questions or comments?

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

Principal Display Panel

MYLANTA ®

LIQUID Tonight

ANTACID + ANTI-GAS

FAST RELIEF OF HEARTBURN AFTER DINNER

Soothing Honey Chamomile Flavor

12 FL OZ (355mL)

Mylanta Tonight, with its soothing honey- chamomile flavor, is perfect for fast heartburn relief in the evening-the time of day when adults suffer heartburn and acid indigestion the most.

Mylanta Tonight is also non–drowsy, so you can use it any time of the day. The great-tasting, soothing liquid, with extra coating power, helps make after-dinner heartburn feel better fast.

• Calcium-rich formula
• Paraben-free
• Smooth, creamy taste

Active ingredients: Calcium carbonate, Magnesium hydroxide, Simethicone

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

Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co.

infirst+

HEALTHCARE

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2017 Infirst Healthcare Inc.

Mylanta.com

INGREDIENTS AND APPEARANCE

MYLANTA NEW TONIGHT SOOTHING HONEY CHAMOMILE 
calcium carbonate,magnesium hydroxide and simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-510
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	270 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)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM CARBONATE (UNII: 45P3261C7T)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (OFF WHITE)	Score
Shape		Size
Flavor	HONEY (CHAMOMILE)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-510-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	03/21/2016

Labeler - Infirst Healthcare Inc. (079159739)