CAREONE EXTRA STRENGTH ASSORTED FRUITS- calcium carbonate tablet, chewable 
FOODHOLD USA

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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Extra Strength Smooth Antacid Assorted Fruit 90 Chewable Tablets

Active ingredient (per tablet)

Calcium Carbonate 750 mg

Purpose

Antacid

Uses

relieves:

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

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-hours
if pregnant do not take more than 6 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

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. Do not swallow tablets whole
do not take for symptoms that persists for more than 2 weeks unless advised by a doctor

Other information

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

SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Inactive ingredients

adipic acid, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6 flavors, magnesium stearate, maltodextrin, starch, sucralose

PRINCIPAL DISPLAY PANEL

CAREONE™

NDC 41520-905-90

Compare to the Active Ingredient in TUMS® Smoothies™ EX*

EXTRA STRENGTH

SMOOTH ANTACID

Calcium Carbonate USP 750 mg

Assorted Fruit Flavors

FOR FAST RELIEF OF:

ACID INDIGESTION
HEARTBURN
UPSET STOMACH

90 CHEWABLE TABLETS

GLUTEN-FREE

DISTRIBUTED. BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

© 2018 S&S Brands, LLC, Quality guaranteed or your money back.

*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of TUMS® Smoothies™EX..

Careone Extra Strength Smooth Antacid 90 Counts
CAREONE EXTRA STRENGTH  ASSORTED FRUITS
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-905
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)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPINK, RED, ORANGE, YELLOWScoreno score
ShapeROUNDSize18mm
FlavorFRUIT (Assorted) Imprint Code RP115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-905-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/19/2019
Labeler - FOODHOLD USA (809183973)

Revised: 8/2023
Document Id: 8e73bd58-3068-411e-8c1e-98422373f568
Set id: 2863d17f-b613-4149-8cfb-7f4a1b40fc79
Version: 5
Effective Time: 20230819
 
FOODHOLD USA