O T Re P: Package Insert and Label Information

O T RE P- calcium carbonate tablet
QN SCIENCE Co Ltd

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.

active ingredients

CALCIUM CARBONATE 64%

purpose

Prevention or treatment osteoporosis

inactive ingredients

Magnesium oxide, Anchovy, Vitamin C, Microcrystalline Cellulose,

Carboxymethyl cellulose, Silanedione, Magnesium Stearate

use

Osteoporosis treatment supplements without side effects

Warnings

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

Warnings

■ do not use more than directed.

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

Warnings

new symptoms occur or symptoms worsen

Warnings

Be careful not to take the included desiccant.

Warnings

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

Directions

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

82932-401

O T Re P Label
(click image for full-size original)
O T RE P
calcium carbonate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82932-401
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 64 mg in 100
Inactive Ingredients
Ingredient Name Strength
SILANDRONE
JAPANESE ANCHOVY
MICROCRYSTALLINE CELLULOSE
ASCORBIC ACID
MAGNESIUM OXIDE
MAGNESIUM STEARATE
CARBOXYMETHYLCELLULOSE
Product Characteristics
Color white Score score with uneven pieces
Shape OVAL Size 22mm
Flavor GRAPEFRUIT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82932-401-01 200 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 09/05/2022
Labeler — QN SCIENCE Co Ltd (695154561)
Registrant — QN SCIENCE Co Ltd (695154561)
Establishment
Name Address ID/FEI Operations
QN SCIENCE Co Ltd 695154561 manufacture (82932-401)

Revised: 09/2022 QN SCIENCE Co Ltd

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