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

Rolaids Extra Strength Fruit by

Drug Labeling and Warnings

Rolaids Extra 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

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:

• 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 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

• chew 2-4 tablets as symptoms occur, or as directed by a doctor  

Other information

each tablet contains: calcium 270 mg, magnesium 55 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 (309-060)

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:

• 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 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

• chew 2-4 tablets as symptoms occur, or as directed by a doctor  

Other information

• each tablet contains: calcium 270 mg, magnesium 55 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 (309-056)

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:

• 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 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

• chew 2-4 tablets as symptoms occur, or as directed by a doctor  

Other information

• each tablet contains: calcium 270 mg, magnesium 55 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 (309-060)

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	675 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	135 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)

Product Characteristics
Color	RED, PURPLE, YELLOW, ORANGE	Score	no score
Shape	ROUND	Size	16mm
Flavor	FRUIT (cherry, grape, lemon, orange)	Imprint Code	R;X
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1002-0	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
2	NDC: 41167-1002-1	96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
3	NDC: 41167-1002-2	116 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013
4	NDC: 41167-1002-3	3 in 1 CELLO PACK	09/01/2013
4	NDC: 41167-1002-4	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)