FDA.reportPublic FDA data

O T Re P

Manufacturer
QN SCIENCE Co Ltd
Effective date
2022-10-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:51:01

Label at a glance#

ProductO T Re P
Active ingredientCALCIUM CARBONATE
Label structure11 sections

Dosage and administration

Adults and children 18 years and over take 3 tablets 2~3 times a day Children 12 to 18 years take 1~2 tablets 2 times a day Children 8 to 12 years take 1/2 tablets 2 times a day

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

CALCIUM CARBONATE 64%

purpose

OTC - PURPOSE SECTION

Prevention or treatment osteoporosis

inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium oxide, Anchovy, Vitamin C, Microcrystalline Cellulose,

Carboxymethyl cellulose, Silanedione, Magnesium Stearate

use

INDICATIONS & USAGE SECTION

Osteoporosis treatment supplements without side effects

Warnings

OTC - DO NOT USE SECTION

if you are allergic to any of the ingredients in this product.

Warnings

OTC - WHEN USING SECTION

■ do not use more than directed.

■ take with enough water or drink to avoid getting into airway.

Warnings

OTC - STOP USE SECTION

new symptoms occur or symptoms worsen

Warnings

WARNINGS SECTION

Be careful not to take the included desiccant.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 18 years and over

take 3 tablets 2~3 times a day

Children 12 to 18 years

take 1~2 tablets 2 times a day

Children 8 to 12 years

take 1/2 tablets 2 times a day

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82932-401

O T Re P LabelO T Re P Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82932-40182932-401-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILANDRONEYY7GL3CCE9IACT
CALCIUM CARBONATEH0G9379FGKACTIB
JAPANESE ANCHOVYS0W8PG7GQEIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
MAGNESIUM OXIDE3A3U0GI71GIACT
MAGNESIUM STEARATE70097M6I30IACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ebc3aa38-3490-e43e-e053-2995a90a6d5be7e8b3e9-e9ac-3a9c-e053-2a95a90a4a532022-10-24WarningsExact identifier
spl id: ebc3aa38-3490-e43e-e053-2995a90a6d5b
spl set id: e7e8b3e9-e9ac-3a9c-e053-2a95a90a4a53

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.