Altrixa OB Tablets PRENATAL/POSTNATAL Dietary Supplement

Manufacturer
Allegis Pharmaceuticals, Inc
Effective date
2025-05-30
Label type
DIETARY SUPPLEMENT
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:37:26

Label at a glance#

ProductAltrixa OB
Active ingredientASCORBIC ACID, BETA CAROTENE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HCL, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, THIAMINE
Label structure12 sections

Dosage and administration

Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

Altrixa OB Tablets - Dispensed by Prescription

STATEMENT OF IDENTITY SECTION

Serving Size: 1 Tablet

Servings Per Container: 30

Each Tablet Contains:

%DV

Vitamin A (as beta-carotene)                     

300 mcg RAE 

66%

Vitamin C (as ascorbic acid) 

125 mg

140%

Vitamin D3 (as cholecalciferol)

12.5 mcg

30%

Vitamin E (as dl-alpha-tocopheryl acetate)

4.5 mg

33%

Vitamin B6 (as pyridoxine HCl)

20 mg

1117%

Folate

(From 588 mcg folic acid

and 442 mcg L-5 MTHF ca salt)

1750 mcg DFE

437.5%

 Vitamin B12 (as cyanocobalamine)

0.03 mg

650%

Biotin

30 mg

10%

Calcium (from calcium carbonate) 

100 mg

7.5%

Iron (as ferrous fumarate)

15 mg

83%

Iodine (as potassium iodide)

150 mcg

100%

Magnesium (as magnesium oxide)

20 mg

5%

Thiamin (as thiamin HCI)                                                                                   1.4 mg                                    100%

** Daily Values (DV) not established.

OTHER INGREDIENTS: Microcrystalline cellulose, powdered cellulose, silica, vegetable steric acid, croscarmellose sodium, vegetable magnesium stearate, coating (hypromellose, hydroxypropyl cellulose, titanium dioxide, polyehylene glycol).

Description

HEALTH CLAIM SECTION

Altrixa OB Tablets is a prescription dietary supplement for use throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. 

Prenate Max Tablets may be useful in improving the nutritional status of women prior to conception.

CONTRADINDICATIONS

HEALTH CLAIM SECTION

Altrixa OB Tablets are contraindicted in patients with a known hypersensitivity to any of the contained ingredients.   Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner. 

WARNING

WARNINGS SECTION

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 the case of accidental overdose, call a doctor or poison control center immediately.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

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

You may report side effects by calling Allegis Pharmaceuticals, Inc at 1-866-633-9033 or the FDA by calling 1-800-FDA-1088. 

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

PRECAUTION:

PRECAUTIONS SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Prenate Max Tablets should only be used under the direction and supervision of a licensed medical practioner. 

​For use under the supervision of a licensed medical practitioner.  Dispense in a tight, light resistant container as defined in the USP/NF in a child-resistant closure. 

How Supplied

HEALTH CLAIM SECTION

How Supplied

Altrixa OB Talets are available as white tablets with "225" embossed and are available in 30 count bottles (28595-721-30*).

Manufactured in the USA for:

Allegis Pharmaceuticals, Inc.

Canton, MS  39046

Rev 05/2025

Statements

HEALTH CLAIM SECTION

These statements have not been evaluated by the FDA.  This product is not intended to diagnose, treat, cure, or prevent any disease.

This product is not an Orange Book Product.

Dispense by Prescrition**

*Allegis Pharmaceuticals, Inc. does not represent these product codes to be National Drug Codes (NDC).  Product codes are formated according  to standard industry practice, to meet the formatting requirements by pedigree reporting and supply-chain control including pharmacies.

** This product is a prescription-folate with or without other dietary ingredients that - due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administratin under the care of a licensed medical practitioner (61 FR 8760).1-3  The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription.  This is not an Orange Book product.  This  product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statutes as applicable.   The ingredients, indication or claims of this product are not to be construed to be a drug claims. 

1. Federal Register Notice of August 2, 1973 (38 FR 20750)

2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)

3. Federal Register Notice of March 5, 1996 (61 FR 8760)

STORAGE

SAFE HANDLING WARNING SECTION

Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from light
and moisture.

Tamper evident: Do not use if seal is broken or missing. 

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-721-30EA - Each28595-721dc3de7c1-acdc-4e38-81cb-a7cc1c095c7612025-07-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
28595-72128595-721-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsName fallback
generic name: ASCORBIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.