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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Rolaids Advanced Antacid

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:

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

Other information

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

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

ROLAIDS ADVANCED ANTACID ANTI-GAS MIXED BERRY 
calcium carbonate and magnesium hydroxide and simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1000 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (assorted colors) , BLUE (assorted colors) , PURPLE (assorted colors) Scoreno score
ShapeROUNDSize20mm
FlavorSTRAWBERRY (assorted flavors) , GRAPE (assorted flavors) , BLUEBERRY (assorted flavors) , BERRY (assorted flavors) Imprint Code R;A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-1040-075 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2015
2NDC:41167-1040-160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2015
3NDC:41167-1040-272 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2015
4NDC:41167-1040-33 in 1 PACKAGE02/02/2015
4NDC:41167-1040-510 in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33102/02/2015
Labeler - Chattem, Inc. (003336013)

Revised: 6/2017
Document Id: d2966b32-2133-45ce-a5d4-a05577688b98
Set id: 3884c05a-a593-424e-88b3-be962e73488e
Version: 4
Effective Time: 20170630
 
Chattem, Inc.