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

Rolaids Advanced Antacid Anti-gas Mixed Berry by

Drug Labeling and Warnings

Rolaids Advanced Antacid Anti-gas Mixed Berry by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1040
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	PINK (assorted colors) , BLUE (assorted colors) , PURPLE (assorted colors)	Score	no score
Shape	ROUND	Size	20mm
Flavor	STRAWBERRY (assorted flavors) , GRAPE (assorted flavors) , BLUEBERRY (assorted flavors) , BERRY (assorted flavors)	Imprint Code	R;A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

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

Labeler - Chattem, Inc. (003336013)