Label: NUTRALOX- calcium carbonate tablet, chewable
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NDC Code(s):
50332-0151-1,
50332-0151-3,
50332-0151-4,
50332-0151-7, view more50332-0151-8
- Packager: HART Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 15, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
Do not take more than directed
Adults and children 12 years of age and over:
- thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur
- do not take more than 16 tablets in 24 hours unless directed by a doctor
- do not use the maximum dose for more than 2 weeks
Children under 12 years of age: ask a doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NUTRALOX
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0151 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 420 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MINERAL OIL (UNII: T5L8T28FGP) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ;036 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50332-0151-3 20 in 1 BOX, UNIT-DOSE 01/20/1987 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:50332-0151-4 50 in 1 BOX, UNIT-DOSE 01/20/1987 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:50332-0151-7 125 in 1 BOX, UNIT-DOSE 01/20/1987 3 2 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:50332-0151-8 250 in 1 BOX, UNIT-DOSE 01/20/1987 4 2 in 1 PACKET; Type 0: Not a Combination Product 5 NDC:50332-0151-1 500 in 1 BOX, UNIT-DOSE 01/20/1987 5 2 in 1 PACKET; 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 01/20/1987 Labeler - HART Health (069560969)