SIGNATURE CARE EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT - calcium carbonate tablet, chewable 
Safeway

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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Signature care Extra Strength Smooth Antacid Assorted Fruit 

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 750 mg

PURPOSE

Antacid

USE(S)

relieves:

  • acid indigestion
  • heartburn

WARNINGS

.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

  • presently 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, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

IF PREGNANT OR BREAST FEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

  • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.

OTHER INFORMATION

  • each tablet contains: elemental calcium 300 mg
  • store at room temperature. keep the container tightly closed.

INACTIVE INGREDIENTS

adipic acid, corn starch, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C red 40 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose, talc.

PRINCIPAL DISPLAY PANEL

Compare to Tums® Smoothies™ E-X active ingredient *
NDC 21130-138-23
Signature care
Extra Strength Smooth
Antacid Relief Tablets
CALCIUM CARBONATE, 750 mg
ASSORTED FRUIT FLAVOR


  • Chewable
  • Rich in calcium
  • Relief of: acid indigestion/heartburn

60 TABLETS

39

SIGNATURE CARE EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-138
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
ADIPIC ACID (UNII: 76A0JE0FKJ)  
STARCH, CORN (UNII: O8232NY3SJ)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
SORBITOL (UNII: 506T60A25R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorPINK (light pink) , RED (light red) , ORANGE (light orange) , YELLOW (light yellow) Scoreno score
ShapeROUNDSize18mm
FlavorCHERRY, LEMON, ORANGE, STRAWBERRYImprint Code G173
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-138-2360 in 1 BOTTLE; Type 0: Not a Combination Product10/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33110/23/2018
Labeler - Safeway (009137209)

Revised: 12/2020
Document Id: 97c439d5-e518-42b3-a5dd-cc358762e1b5
Set id: 013841fd-a4ed-495b-b38d-6ce81d65d120
Version: 2
Effective Time: 20201211
 
Safeway