ROLAIDS ULTRA STRENGTH FRUIT- calcium carbonate and magnesium hydroxide tablet, chewable

Rolaids Ultra Strength Fruit by

Drug Labeling and Warnings

Rolaids Ultra Strength Fruit by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• heartburn
  
• sour stomach
  
• acid indigestion

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

• contains FD&C yellow no. 5 (tartrazine)

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:

• heartburn
  
• sour stomach
  
• acid indigestion

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
  
• contains FD&C yellow no. 5 (tartrazine) as a color additive

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:

• heartburn
  
• sour stomach
  
• acid indigestion

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
  
• contains FD&C yellow no. 5 (tartrazine) as a color additive

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

PRINCIPAL DISPLAY PANEL

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 

INGREDIENTS AND APPEARANCE

ROLAIDS ULTRA STRENGTH FRUIT 
calcium carbonate and magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1004
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	RED, PURPLE, YELLOW, ORANGE	Score	no score
Shape	ROUND	Size	19mm
Flavor	FRUIT (cherry, grape, lemon, orange)	Imprint Code	R;U
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1004-1	72 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
2	NDC: 41167-1004-2	87 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
3	NDC: 41167-1004-3	160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
4	NDC: 41167-1004-5	3 in 1 CELLO PACK	09/01/2013
4	NDC: 41167-1004-4	10 in 1 PACKAGE; 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	09/01/2013

Labeler - Chattem, Inc. (003336013)