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:

Virtus Pharmaceuticals

INN (International Name):

Magnesium Oxide

Composition:

Magnesium Oxide 400 mg

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

MAGNESIUM OXIDE- MAGNESIUM OXIDE TABLET
VIRTUS 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._
----------
MAGNESIUM OXIDE
_DRUG FACTS_
ACTIVE INGREDIENT
Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)
PURPOS E
Antacid
US E
relieves:
acid indigestion
upset stomach
WARNINGS
ASK A DOCTOR BEFORE USE IF
you have kidney disease
you are taking a prescription drug (antacids may interact with certain
prescription drugs)
you are pregnant or breast feeding.
DO NOT TAKE more than 2 tablets in a 24 hour period.
May have a laxative effect.
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
take one or two antacid tablets daily. Do not exceed two tablets
unless directed by a physician.
OTHER INFORMATION
Store at controlled room temperature 15° to 30°C (59° to 86°F).
Tamper evident, do not use if imprinted safety seal under cap is
broken or missing.
INACTIVE INGREDIENTS
Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide,
and Stearic Acid.
QUES TIONS ?
Call Virtus at 1-888-848-3593 M-F, 8:30 - 5 EST or FDA at
1-800-FDA-1088
PRINCIPAL DISPLAY PANEL - 120 TABLET BOTTLE LABEL
69543-217-12
MAGNES IUM
OXIDE 400 MG
241.3 mg Elemental Magnesium
Antacid
No sugar, gluten, yeast, corn, wheat,
milk, artificial colors, flavors or
preservatives added.
120 TABLETS
VIRTUS
PHARMACEUTICALS
MAGNESIUM OXIDE
magnesium oxide tablet
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 543-217
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MA G NESIUM O XIDE (UNII: 3A3U0 GI71G) (Magnesium Catio n - UNII:T6
V3LHY8 38 )
Magnesium Oxide
40 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CRO SCA RMELLO SE SO DIUM (UNII: M28 OL1HH48 )
CELLULO SE, MICRO CRYSTA LLINE (UNII: OP1R32D6 1U)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
Virtus Pharmaceuticals
STEA RIC ACID (UNII: 4ELV7Z6 5AP)
PR