SPL v1
SPL
SPL Set ID 60bb4830-2079-17eb-e053-2a91aa0a60ae
Route
ORAL
Published
Effective Date 2017-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (400 mg)
Inactive Ingredients
Croscarmellose Cellulose, Microcrystalline Stearic Acid Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: white Size: 11 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-16

Description

Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

Purpose

relieves: acid indigestion upset stomach

Dosage and Administration

take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.


Medication Information

Purpose

relieves:

acid indigestion

upset stomach

Dosage and Administration

take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.

Description

Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

Warnings

Do not take this product if you are presently taking a prescription drug without consulting your physician or other health care professional. If you have kidney disease, take only under the supervision of a physician. May have a laxative effect. If pregnant or breast-feeding, ask a health professional before use.

Pregnancy or Breast Feeding

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

Keep Out of Reach of Children

Active Ingredient

Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

Storage & Handling

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.

Indications & Usage

Antacid

Inactive Ingredients

Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.

Keep Out of Reach of Children

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.

Package Label. Prinicpal Display Panel


Structured Label Content

Purpose

relieves:

acid indigestion

upset stomach

Warnings

Do not take this product if you are presently taking a prescription drug without consulting your physician or other health care professional. If you have kidney disease, take only under the supervision of a physician. May have a laxative effect. If pregnant or breast-feeding, ask a health professional before use.

Pregnancy or Breast Feeding

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

Keep Out of Reach of Children

Active Ingredient

Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

Storage & Handling

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.

Indications & Usage

Antacid

Inactive Ingredients

Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.

Dosage and Administration

take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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.

Package Label. Prinicpal Display Panel


Advanced Ingredient Data


Raw Label Data

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