ROLAIDS ULTRA 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 Ultra Strength Tablets Fruit

Ultra Strength Antacid Rolaids Assorted Fruit 10 Chewable Tablets

Drug Facts

Active ingredient

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

each tablet contains: calcium 400 mg, magnesium 85 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 (309-062)

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

Ultra Strength Antacid Rolaids Assorted Fruit 72 Chewable Tablets

Drug Facts

Active ingredient

(in each tablet)
Calcium carbonate USP 1000 mg
Magnesium hydroxide USP 200 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 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, dextrose, flavors, magnesium stearate, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose, yellow 5 lake, yellow 6 lake (309-057)

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

Supplement Facts
Serving Size: 2 Tablets, Servings Per Container: 36, Amount Per Serving: Calories 12, Total Carb 2 g (<1% DV*), Sugars 2 g (†DV), Calcium 800 mg (80% DV), Magnesium 170 mg (42% 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

Ultra Strength Antacid Rolaids Assorted Fruit 30 Chewable Tablets

Drug Facts

Active ingredient

(in each tablet)
Calcium carbonate USP 1000 mg
Magnesium hydroxide USP 200 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 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, dextrose, flavors, magnesium stearate, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose, yellow 5 lake, yellow 6 lake (309-062)

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

PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH ANTACID
Rolaids®
10 Assorted Fruit Chewable Tablets

ULTRA STRENGTH ANTACID
Rolaids®
10 Assorted Fruit Chewable Tablets

PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH ANTACID
Rolaids®
Rapid Relief of:
Heartburn
Acid Indigestion
72 Chewable Tablets
Assorted Fruit

ULTRA STRENGTH ANTACID
Rolaids®
Rapid Relief of:
Heartburn
Acid Indigestion
72 Chewable Tablets
Assorted Fruit

PRINCIPAL DISPLAY PANEL

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

ROLAIDS ULTRA STRENGTH FRUIT 
calcium carbonate and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 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)  
Product Characteristics
ColorRED, PURPLE, YELLOW, ORANGEScoreno score
ShapeROUNDSize19mm
FlavorFRUIT (cherry, grape, lemon, orange) Imprint Code R;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-1004-172 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
2NDC:41167-1004-287 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
3NDC:41167-1004-3160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
4NDC:41167-1004-53 in 1 CELLO PACK09/01/2013
4NDC:41167-1004-410 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: 16ffeec5-41c6-4a77-9296-9498f44385a4
Set id: 50aa27e4-00c9-477a-88c0-a10de1fa3f75
Version: 4
Effective Time: 20130901
 
Chattem, Inc.