ROLAIDS EXTRA STRENGTH FRUIT- calcium carbonate and magnesium hydroxide 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 Extra Strength Tablets Fruit

Extra Strength Antacid Rolaids Assorted Fruit 10 Chewable Tablets

Drug Facts

Active ingredient

(in each tablet)
Calcium carbonate USP 675 mg
Magnesium hydroxide USP 135 mg

Purpose

Antacid

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 10 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

each tablet contains: calcium 270 mg, magnesium 55 mg

Inactive ingredients

blue 1 lake, dextrose, flavors, magnesium stearate, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose, yellow 5 lake, yellow 6 lake (309-060)

Dist. by CHATTEM, INC.
P.O. Box 2219
Chattanooga, TN 37409

Extra Strength Antacid Rolaids Assorted Fruit 96 Chewable Tablets

Drug Facts

Active ingredient

(in each tablet)
Calcium carbonate USP 675 mg
Magnesium hydroxide USP 135 mg

Purpose

Antacid

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 10 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, dextrose, flavors, magnesium stearate, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose, yellow 5 lake, yellow 6 lake (309-056)

As a daily source of calcium and magnesium, chew 2 tablets twice daily.

Supplement Facts
Serving Size: 2 Tablets, Servings Per Container: 48, Amount Per Serving: Calories 8, Total Carb 2 g (<1% DV*), Sugars 2 g (†DV), Calcium 540 mg (54% DV), Magnesium 110 mg (29% DV). *Percent Daily Values (DV) are based on a 2,000 calories diet.
†Daily Value not established.

Other ingredients

sucrose, dextrose, stearic acid, magnesium stearate, silicon dioxide, natural and artificial flavors, red 40 lake, yellow 6 lake, yellow 5 lake, blue 1 lake, sucralose

Extra Strength Antacid Rolaids Assorted Fruit 30 Chewable Tablets

Drug Facts

Active ingredient

(in each tablet)
Calcium carbonate USP 675 mg
Magnesium hydroxide USP 135 mg

Purpose

Antacid

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 10 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, dextrose, flavors, magnesium stearate, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose, yellow 5 lake, yellow 6 lake (309-060)

Dist. by CHATTEM, INC.
P.O. Box 2219
Chattanooga, TN 37409

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH ANTACID
Rolaids®
10 Assorted Fruit Chewable Tablets

EXTRA STRENGTH ANTACID
Rolaids®
10 Assorted Fruit Chewable Tablets

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH
Rolaids®
ANTACID/ CALCIUM & MAGNESIUM SUPPLEMENT
Goes to Work
INSTANTLY 
96 Chewable Tablets
Assorted Fruit

EXTRA STRENGTH
Rolaids®
ANTACID/ CALCIUM & MAGNESIUM SUPPLEMENT
Goes to Work
INSTANTLY 
96 Chewable Tablets
Assorted Fruit

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH
Rolaids®
ANTACID
Rapid Relief of:
Heartburn
Acid Indigestion
3 Rolls
30 Chewable Tablets
Assorted Fruit 

PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH 
Rolaids®
ANTACID
Rapid Relief of:
Heartburn
Acid Indigestion
3 Rolls 
30 Chewable Tablets
Assorted Fruit

ROLAIDS EXTRA STRENGTH FRUIT 
calcium carbonate and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE675 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE135 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DEXTROSE (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
ColorRED, PURPLE, YELLOW, ORANGEScoreno score
ShapeROUNDSize16mm
FlavorFRUIT (cherry, grape, lemon, orange) Imprint Code R;X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-1002-0120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
2NDC:41167-1002-196 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
3NDC:41167-1002-2116 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
4NDC:41167-1002-33 in 1 CELLO PACK09/01/2013
4NDC:41167-1002-410 in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33109/01/2013
Labeler - Chattem, Inc. (003336013)

Revised: 9/2013
Document Id: 3edd9a44-59bc-4f05-87ca-29ab8e062002
Set id: ce2af1a6-0387-41e5-ad06-85b790bd4120
Version: 6
Effective Time: 20130901
 
Chattem, Inc.