O T RE P- calcium carbonate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM CARBONATE 64%

Available from:

QN SCIENCE Co Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Prevention or treatment osteoporosis Osteoporosis treatment supplements without side effects

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
OSTEOPOROSIS TREATMENT RESTORATION PERFECT.
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
calcium carbonate tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82932-401
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION -
UNII:2M83C4R6Z B)
CALCIUM CARBONATE
64 mg
in 100
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILANDRONE (UNII: YY7GL3CCE9)
JAPANESE ANCHOVY (UNII: S0W8PG7GQE)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
PRODUCT CHARACTERISTICS
COLOR
white
SCORE
score with uneven pieces
QN SCIENCE Co Ltd
COLOR
SCORE
SHAPE
OVAL
SIZE
22mm
FLAVOR
GRAPEFRUIT
IMPRINT CODE
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
D