NUTRALOX- calcium carbonate tablet, chewable 
HART Health

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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NUTRALOX

Active Ingredient (in each tablet): Calcium Carbonate 420 mg

Purpose: Antacid

Uses: Temporarily relieves

Warnings:

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interfere with certain prescription drugs.

Stop use and ask a doctor if symptoms last for more than 2 weeks

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions:

Do not take more than directed

Adults and children 12 years of age and over:

Children under 12 years of age: ask a doctor

Inactive Ingredients: Acacia Gum, Flavor, Magnesium Stearate, Maltodextrin, Silicon Dioxide, Starch, Sucrose

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NUTRALOX 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE420 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SUCROSE (UNII: C151H8M554)  
ACACIA (UNII: 5C5403N26O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code NLX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0106-320 in 1 BOX, UNIT-DOSE01/20/1987
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0106-450 in 1 BOX, UNIT-DOSE01/20/1987
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:50332-0106-7125 in 1 BOX, UNIT-DOSE01/20/1987
32 in 1 PACKET; Type 0: Not a Combination Product
4NDC:50332-0106-8250 in 1 BOX, UNIT-DOSE01/20/1987
42 in 1 PACKET; Type 0: Not a Combination Product
5NDC:50332-0106-1500 in 1 BOX, UNIT-DOSE01/20/1987
52 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/20/1987
Labeler - HART Health (069560969)

Revised: 6/2020
Document Id: 7c0948f2-8cf5-4f32-a823-f7a27e6a04ce
Set id: 263e20ca-1ca6-4f7c-bae5-525a1184b744
Version: 3
Effective Time: 20200605
 
HART Health