MAGNESIUM OXIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)

Available from:

PAR Pharmaceuticals

INN (International Name):

MAGNESIUM OXIDE

Composition:

MAGNESIUM OXIDE 400 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Relieves: ■ acid indigestion  ■ upset stomach

Authorization status:

OTC monograph final

Summary of Product characteristics

MAGNESIUM OXIDE- MAGNESIUM OXIDE TABLET
PAR PHARMACEUTICALS
_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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MAGNESIUM OXIDE TABLETS
ACTIVE INGREDIENT (IN EACH TABLET)
Magnesium Oxide 400mg (240mg Elemental Magnesium)
PURPOS E
Antacid
USES
Relieves: ■ acid indigestion ■ upset stomach
WARNINGS
ASK A DOCTOR IF YOU HAVE:
kidney disease
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE:
taking a prescription drug. Antacids may interact with certain
prescription drugs.
DO NOT TAKE
more than 2 tablets in a 24 hour period or use the maximum dosage of
this product for more than two
weeks, except under the advise and supervision of a physician. May
have a laxative effect.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
ANTACID DIRECTIONS: ■ take 1 tablet twice a day or as directed by a
physician
MAGNESIUM SUPPLEMENT DIRECTIONS: ■ take 1 to 2 tablets daily or as
directed by a physician
OTHER INFORMATION
■ store at controlled room temperature 59°-86° F (15°-30°C) ■
do not use if imprinted safety seal under
cap is broken or missing
■ Magnesium content per tablet: 240 mg
INACTIVE INGREDIENTS
colloidal silicon dioxide, croscarmellose sodium, microcrystalline
cellulose, stearic acid
PRINCIPAL DISPLAY PANEL
MAG NESIUM OXIDE TABLETS 4 20MG
MAGNESIUM OXIDE
magnesium oxide tablet
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 6 0 3-0 20 9
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MAGNESIUM O XIDE (UNII: 3A3U0 GI71G) (MAGNESIUM CATION - UNII:T6
V3LHY8 38 )
MAGNESIUM OXIDE
40 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
PRODU