Rolaids Advanced Antacid Anti-Gas Mixed Berry (Calcium Carbonate And Magnesium Hydroxide And Simethicone) Tablet, Chewable [Chattem, Inc.] -

ROLAIDS ADVANCED ANTACID ANTI-GAS MIXED BERRY (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [CHATTEM, INC.]
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SPL UNCLASSIFIED SECTION

MULTI-SYMPTOM Rolaids ADVANCED ANTACID PLUS ANTI-GAS

Drug Facts
Active ingredients

(in each tablet)
Calcium carbonate USP 1000 mg
Magnesium hydroxide USP 200 mg
Simethicone USP 40 mg
Purpose

Antacid
Antacid
Antigas
Use
relieves:
- heartburn
- sour stomach
- acid indigestion
- upset stomach associated with these symptoms
- pressure and bloating commonly referred to as gas
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 take more than 7 tablets in a 24-hour period
- do not use the maximum dosage for more than 2 weeks
Keep out of reach of children.
Directions
- chew 2-3 tablets as symptoms occur, or as directed by a doctor
Other information
- each tablet contains: calcium 400 mg, magnesium 85 mg
Inactive ingredients

blue 1 lake, blue 2 lake, dextrose, magnesium stearate, maltodextrin, natural and artificial flavors, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose (309-145)
PRINCIPAL DISPLAY PANEL

MULTI-SYMPTOM
Rolaids®
ADVANCED
ANTACID PLUS ANTI-GAS
60 Chewable Tablets
Mixed Berries

INGREDIENTS AND APPEARANCE

ROLAIDS ADVANCED ANTACID ANTI-GAS MIXED BERRY
calcium carbonate and magnesium hydroxide and simethicone tablet, chewable

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	1000 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	PINK (assorted colors) , BLUE (assorted colors) , PURPLE (assorted colors) , RED (assorted colors)	Score	no score
Shape	ROUND	Size	19mm
Flavor	RASPBERRY (assorted flavors) , BLACKBERRY (assorted flavors) , BERRY (assorted flavors) , STRAWBERRY (assorted flavors) , BLUEBERRY (assorted flavors)	Imprint Code	R;A
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-1040-0	75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2015
2	NDC:41167-1040-1	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2015
3	NDC:41167-1040-2	72 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2015
4	NDC:41167-1040-3	3 in 1 PACKAGE	02/02/2015
4	NDC:41167-1040-5	10 in 1 CELLO PACK; Type 0: Not a Combination Product
5	NDC:41167-1040-5	10 in 1 CELLO PACK; Type 0: Not a Combination Product	02/02/2015	01/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	02/02/2015

Labeler - Chattem, Inc. (003336013)

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