ROLAIDS HEARTBURN SOOTHERS- calcium carbonate and magnesium hydroxide lozenge

Rolaids Heartburn Soothers by

Drug Labeling and Warnings

Rolaids Heartburn Soothers by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ROLAIDS Heartburn Soothers - Wintermint (Lozenges) 

Drug Facts

Active ingredients (in each lozenge)

Purpose

Calcium carbonate USP 440 mg....................................................................................................................Antacid

Magnesium hydroxide USP 90 mg……………………………………..………...……………………………….. Antacid

Uses

relieves ■ heartburn ■ sour stomach ■ acid indigestion 

Warnings

Ask a doctor or pharmacist before use if you

are now taking a prescription drug. Antacids may interact with certain prescription drugs. 

When using this product

■ do not use more than 15 lozenges in a 24-hour period

■ do not use the maximum dosage for more than 2 weeks 

Keep out of reach of children.

Directions

■ use 2-3 lozenges as symptoms occur, or as directed by a doctor

Other information

■ each lozenge contains: calcium 175 mg, magnesium 40 mg

Inactive ingredients

sucrose, corn syrup, glycerin, water, flavor, hydrogenated coconut oil, propylene glycol, menthol, blue 1

PRINCIPAL DISPLAY PANEL

ROLAIDS
Antacid
Heartburn Soothers
Wintermint (Lozenges)
18 Lozenges

PRINCIPAL DISPLAY PANEL

ROLAIDS
Antacid
Heartburn Soothers
Wintermint (Lozenges)
36 Lozenges

INGREDIENTS AND APPEARANCE

ROLAIDS HEARTBURN SOOTHERS 
calcium carbonate and magnesium hydroxide lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1092
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	440 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	90 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	BLUE (blue-green)	Score	no score
Shape	ROUND	Size	20mm
Flavor	MINT (Wintermint)	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1092-5	2 in 1 CARTON	02/01/2019	01/31/2021
1		9 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-1092-8	3 in 1 CARTON	02/01/2019	05/13/2021
2		9 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part331	02/01/2019	05/13/2021

Labeler - Chattem, Inc. (003336013)