Rolaids Ultra Strength Antacid Softchews

Rolaids Ultra Strength Antacid Softchews

Drug Labeling and Warnings

Drug Details

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ROLAIDS ULTRA STRENGTH ANTACID STRAWBERRY- calcium carbonate and magnesium hydroxide tablet, chewable 
ROLAIDS ULTRA STRENGTH ANTACID ORANGE- 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.

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Rolaids Ultra Strength Antacid Softchews

ULTRA STRENGTH ANTACID Rolaids Softchews- Strawberry

Drug Facts

Active ingredients

(in each chew)
Calcium carbonate USP 1330 mg
Magnesium hydroxide USP 235 mg

Purpose

Antacid
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 5 chews 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 chews as symptoms occur, or as directed by a doctor  

Other information

each tablet contains: calcium 535 mg, magnesium 100 mg

Inactive ingredients

corn starch, corn syrup, corn syrup solids, glycerin, hydrogenated coconut oil, lecithin, natural and artificial flavors, red 40 lake, sucrose, water (309-099)

ULTRA STRENGTH ANTACID Rolaids Softchews- Orange

Drug Facts

Active ingredients

(in each chew)
Calcium carbonate USP 1330 mg
Magnesium hydroxide USP 235 mg

Purpose

Antacid
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 5 chews 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 chews as symptoms occur, or as directed by a doctor  

Other information

each tablet contains: calcium 535 mg, magnesium 100 mg

Inactive ingredients

corn starch, corn syrup, corn syrup solids, glycerin, hydrogenated coconut oil, lecithin, natural and artificial flavors, sucrose, water. yellow 6 lake (309-100)

PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH ANTACID
Rolaids®
Softchews
6 Strawberry Chews

ULTRA STRENGTH ANTACID
Rolaids®
Softchews
6 Strawberry Chews

PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH ANTACID
Rolaids®
Softchews
6 Orange Chews

ULTRA STRENGTH ANTACID
Rolaids®
Softchews
6 Orange Chews

ROLAIDS ULTRA STRENGTH ANTACID STRAWBERRY 
calcium carbonate and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41167-1031
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1330 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE235 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CORN SYRUP (UNII: 9G5L16BK6N)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINKScoreno score
ShapeRECTANGLESize20mm
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41167-1031-11 in 1 CARTON12/01/2014
16 in 1 PACKAGE; Type 0: Not a Combination Product
2NDC: 41167-1031-22 in 1 PACKAGE; Type 0: Not a Combination Product12/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33112/01/2014
ROLAIDS ULTRA STRENGTH ANTACID ORANGE 
calcium carbonate and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41167-1030
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1330 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE235 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CORN SYRUP (UNII: 9G5L16BK6N)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGEScoreno score
ShapeRECTANGLESize20mm
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41167-1030-71 in 1 CARTON12/01/2014
16 in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33112/01/2014
Labeler - Chattem, Inc. (003336013)

Revised: 12/2014
 
Chattem, Inc.


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