Moms Choice Rx

Manufacturer
PruGen, Inc.
Effective date
2013-04-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:16:42

Label at a glance#

ProductMoms Choice Rx
Active ingredientBETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM, ZINC OXIDE, CUPRIC CATION, IODINE, OMEGA-3 FATTY ACIDS
Label structure6 sections

Boxed warning

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Storage and handling

Store at room temperature Keep out of reach of children Manufactured for: PruGen inc. Pharmaceuticals 8714 E Vista Bonita Dr Scottsdale, AZ 85255

Label contents#

Full prescribing information#

DESCRIPTION SECTION

SUPPLEMENT FACTS
Serving Size 1 Tablet:
VITAMINS
A (beta carotene)  . . . . . . . . . . . . . . . . . . . . . . . . . . 2,840 IU    36% Daily Value
C (ascorbic acid)    . . . . . . . . . . . . . . . . . . . . . . . . . . 120 mg    200% Daily Value
D (cholecalciferol)    . . . . . . . . . . . . . . . . . . . . . . . . .840 IU    210% Daily Value
E (dl-alpha tocopheryl acetate)  . . . . . . . . . . . . . .2 mg    7% Daily Value
B1 (thiamine mononitrate)  . . . . . . . . . . . . . . . . . . .1.5 mg    88% Daily Value
B2 (riboflavin)   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 mg    200% Daily Value
Niacinamide   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 mg    100% Daily Value
B6 (pyridoxine hydrochloride)  . . . . . . . . . . . . . . .50 mg    2000% Daily Value
Folic acid    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 mg    125% Daily Value
B12 (cyanocobalamin)   . . . . . . . . . . . . . . . . . . . . . . 12 mcg    150% Daily Value

MINERALS
Calcium (calcium carbonate)  . . . . . . . . . . . . . . . . 215 mg    17% Daily Value
Iron (as sodium iron EDTA and polysaccharide iron complex) . . .26 mg    144% Daily Value

Iodine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210 mcg  140% Daily Value
Magnesium (magnesium oxide)  . . . . . . . . . . . . . 25 mg    6% Daily Value
Zinc (zinc oxide)  . . . . . . . . . . . . . . . . . . . . . . . . .  . . . 25 mg    167% Daily Value
Copper (cupric oxide)  . . . . . . . . . . . . . . . . . . . . . . . .2 mg    100% Daily Value

Serving Size 1 Softgel:
at least 278 mg purified omega-3 fatty acids (as DHA, EPA, ALA, and DPA)

OTHER TABLET INGREDIENTS:
Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Crospovidone, Maltodextrin, Acacia Gum, Silicon Dioxide, Triacetin, Magnesium Stearate, Titanium Dioxide, Polydextrose, Yellow #6 Lake, Blue #2 Lake, Red #40 Lake.

OTHER SOFTGEL INGREDIENTS:
Ammonium Hydroxide, Ethylcellulose, Gelatin, Glycerin, Medium Chain Triglycerides, Oleic Acid, Sodium Alginate, Stearic Acid, Vanillin.
Softgel contains fish and soybeans

INSTRUCTIONS FOR USE SECTION

Directions:  
Before, during and after pregnancy, one tablet and one enteric-coated softgel capsule taken by mouth daily, or as directed by a physician.

Use:  To provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception. 

WARNINGS AND PRECAUTIONS SECTION

Warnings:  Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. 

Precautions:  Folic acid especially in doses above 1.0 mg daily may obscure pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day. Since daily ingestion of more than 3 grams (3,000 mg) per day of omega-3 fatty acids (including alphalinolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

BOXED WARNING SECTION

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

STORAGE AND HANDLING SECTION

Store at room temperature

Keep out of reach of children

Manufactured for:

PruGen inc. Pharmaceuticals

8714 E Vista Bonita Dr

Scottsdale, AZ 85255

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of box
image of box

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42546-190-302019-11-27C16284748780-19855d018-ed3e-cd31-e053-dbdaa90ab51aMom's Choice Rx

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-190-30Moms Choice Rx1 in 1 BLISTER PACKKIT11
42546-190-30Moms Choice Rx6 in 1 CARTONKIT61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-190MOMS CHOICE RX (BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, SODIUM FEREDETATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IRON SUCROSE, IODINE, OMEGA 3 FATTY ACIDS ) KIT [PRUGEN, INC.]1Legacy NDC, 2 package rows20130401_b8400f29-12dd-4b65-9b05-79f34120932d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-190-30EA - Each42546-190204c2c85-d576-4754-823a-3698354771a312013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, D-ACTIVE INGREDIENTA7E6112E4N1
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R1
BETA CAROTENEACTIVE INGREDIENT01YAE03M7J1
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
CUPRIC CATIONACTIVE INGREDIENT8CBV67279L1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
IODINEACTIVE INGREDIENT9679TC07X41
IRONACTIVE INGREDIENTE1UOL152H71
MAGNESIUMACTIVE INGREDIENTI38ZP9992A1
NIACINAMIDEACTIVE INGREDIENT25X51I8RD41
OMEGA-3 FATTY ACIDSACTIVE INGREDIENT71M78END5S1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR1
THIAMINEACTIVE INGREDIENTX66NSO3N351
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
.ALPHA.-TOCOPHEROL, D-ACTIVE MOIETYN9PR3490H91
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
BETA CAROTENEACTIVE MOIETY01YAE03M7J1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
FOLIC ACIDACTIVE MOIETY935E97BOY81
IODINEACTIVE MOIETY9679TC07X41
IRONACTIVE MOIETYE1UOL152H71
MAGNESIUMACTIVE MOIETYI38ZP9992A1
NIACINAMIDEACTIVE MOIETY25X51I8RD41
OMEGA-3 FATTY ACIDSACTIVE MOIETY71M78END5S1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
RIBOFLAVINACTIVE MOIETYTLM2976OFR1
THIAMINE IONACTIVE MOIETY4ABT0J945J1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42546-19042546-190-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1ace1b62-3565-4486-ac54-94a2a1b74554b8400f29-12dd-4b65-9b05-79f34120932d2013-04-01Boxed warning, WarningsExact identifier
spl id: 1ace1b62-3565-4486-ac54-94a2a1b74554
spl set id: b8400f29-12dd-4b65-9b05-79f34120932d

Reported adverse events (FAERS/openFDA)#

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