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CitraNatal Prenatal Tablet

Product Information

Form
Tablet or Pill
UPC
3 01780 83230 1
Product Type
Multi-Vitamin and Mineral (MVM)
DSLD Entry Date
2014-10-10

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

All Ingredients

IngredientAmount% DV
Vitamin C120 mg
Calcium120 mg
Iron20 mg
Vitamin D400 IU
Vitamin B625 mg
Folate1 mg

† Daily Value not established.

Label Statements

General Statements: All Other Content

Rx Only

General Statements: All Other Content

The gentle option for additional B6

General Statements: All Other Content

Rx Prenatal Vitamin and two 25 mg each Vitamin B6 tablets

Formula re: Contains

A prescription prenatal supplement with 1 mg of folic acid and a high level of vitamin B6 which may act as an antiemetic.

Seals/Symbols

march of dimes(R)

General Statements: All Other Content

Mission Pharmacal is a proud support of the March of Dimes.

Seals/Symbols

Mission(R) PHARMACAL

Brand IP Statement(s) re: (c), (TM), (SM)

DESCRIPTION: CitraNatal B-Calm(R) is a prescription prenatal multivitamin/mineral tablet with B6, along with two vitamin B6 tablets. The prenatal tablet contains Ferr-Ease(R), a patented dualiron delivery comprising both a quick release and slow release iron.

Formula re: Contains

CitraNatal B-Calm(R) is a prescription prenatal multivitamin/mineral tablet with B6, along with two vitamin B6 tablets. The prenatal tablet contains Ferr-Ease(R), a patented dualiron delivery comprising both a quick release and slow release iron.

General Statements: All Other Content

The prenatal tablet is white, coated, modified oval, and is debossed with "0832" on one side and is blank on the other.

Formula re: Type

INDICATIONS CitraNatal B-Calm(R) is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Brand IP Statement(s) re: (c), (TM), (SM)

CitraNatal B-Calm(R) may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.

Precautions re: All Other

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions re: Children

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

General Statements: All Other Content

N

General Statements: All Other Content

MP0092

Precautions re: All Other

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. PRECAUTION: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Precautions re: Allergies

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: One tablet every eight hours, beginning with "Tablet 1", or as directed by a physician.

Storage

Store at controlled room temperature.

Precautions re: All Other

NOTICE: Contact with moisture can discolor or erode tablets.

General Statements: All Other Content

HOW SUPPLIED: Six child-resistant blister packs of 5 multivitamin/multimineral tablets and 10 vitamin B6 tablets each - NDC 0178-0832-30.

General Statements: All Other Content

To report a serious adverse event or obtain product information, call (210) 696-8400.

Seals/Symbols

Ferr-Ease(R) Dual-iron delivery

Brand IP Statement(s) re: (c), (TM), (SM)

Trademark of Mission Pharmacal Company U.S. Patent No. 6,521,247

Brand IP Statement(s) re: (c), (TM), (SM)

Copyright (C) 2011 Mission Pharmacal Company. All rights reserved.

General Statements: All Other Content

March of Dimes does not endorse specific products or brands.

Brand IP Statement(s) re: (c), (TM), (SM)

March of Dimes is a registered trademark of the March of Dimes Foundation.

Seals/Symbols

Mission(R) PHARMACAL

General Statements: All Other Content

Prenatal vitamin supplementation plus additional vitamin B6 which may help relieve nausea and vomiting.

General: Product/Version Code

50310 C01 Rev 008110

Supplement Facts Panel

Supplement Facts
Serving Size 1 Tablet(s)
Amount Per Serving% Daily Value*
Vitamin C
120 mg
Calcium
120 mg
Iron
20 mg
Vitamin D
400 IU
Vitamin B6
25 mg
Folate
1 mg

* Percent Daily Values are based on a 2,000 calorie diet.

† Daily Value not established.

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