FDA.reportPublic FDA data

Bal-Care DHA

Manufacturer
PruGen, Inc.
Effective date
2012-05-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 20:15:18

Label at a glance#

ProductBal-Care DHA
Active ingredientBETA 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
Label structure5 sections

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)  . . . . . . . . . . . . . . . . . . . . . . . . . . 2,850 IU    36% Daily Value
C (ascorbic acid)    . . . . . . . . . . . . . . . . . . . . . . . . . . 120 mg    200% Daily Value
D (cholecalciferol)    . . . . . . . . . . . . . . . . . . . . . . . . .840 IU    210% Daily Value
E (dl-alpha tocopheryl acetate)  . . . . . . . . . . . . . .3 mg    10% Daily Value
B1 (thiamine mononitrate)  . . . . . . . . . . . . . . . . . . .1.8 mg    106% 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)  . . . . . . . . . . . . . . . . 219 mg    17% Daily Value
Iron (as sodium iron EDTA and polysaccharide iron complex) . . .27 mg    150% 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

Service Size 1 Softgel:
430 mg purified omega-3 fatty acids including:
At least 295 mg DHA (docosahexaenoic acid); also contains at least 135 mg of other omega-3 fatty acids.

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

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.

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.

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 Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
COPPER 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
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42546-180-302019-11-13C16284748780-197449f38-cb21-f6ea-e053-dbdaa90aa703Bal-Care DHA Rev 1.1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-180-30Bal-Care DHA1 in 1 BLISTER PACKKIT15
42546-180-30Bal-Care DHA6 in 1 CARTONKIT65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-180BAL-CARE DHA (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.]5Legacy NDC, 2 package rows20120612_b2f0ca0d-76e9-45f0-bf60-e9781c227676.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-180-30EA - Each42546-180da9a5d24-14e6-4687-843c-30f8a97460ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, DL-ACTIVE INGREDIENTWR1WPI7EW85
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R5
BETA CAROTENEACTIVE INGREDIENT01YAE03M7J5
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK5
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF415
CUPRIC OXIDEACTIVE INGREDIENTV1XJQ704R45
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2045
FOLIC ACIDACTIVE INGREDIENT935E97BOY85
IODINEACTIVE INGREDIENT9679TC07X45
IRON SUCROSEACTIVE INGREDIENTFZ7NYF5N8L5
MAGNESIUM OXIDEACTIVE INGREDIENT3A3U0GI71G5
NIACINAMIDEACTIVE INGREDIENT25X51I8RD45
OMEGA-3 FATTY ACIDSACTIVE INGREDIENT71M78END5S5
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV5
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR5
SODIUM FEREDETATEACTIVE INGREDIENT403J23EMFA5
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919X5
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z5
.ALPHA.-TOCOPHEROL ACETATE, DL-ACTIVE MOIETYWR1WPI7EW85
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R5
CALCIUMACTIVE MOIETYSY7Q814VUP5
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF415
COPPERACTIVE MOIETY789U1901C55
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2045
FOLIC ACIDACTIVE MOIETY935E97BOY85
IODINEACTIVE MOIETY9679TC07X45
IRONACTIVE MOIETYE1UOL152H75
MAGNESIUMACTIVE MOIETYI38ZP9992A5
NIACINAMIDEACTIVE MOIETY25X51I8RD45
OMEGA-3 FATTY ACIDSACTIVE MOIETY71M78END5S5
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z5
RIBOFLAVINACTIVE MOIETYTLM2976OFR5
THIAMINEACTIVE MOIETYX66NSO3N355
VITAMIN AACTIVE MOIETY81G40H8B0T5
ZINCACTIVE MOIETYJ41CSQ7QDS5

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42546-18042546-180-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA CAROTENE01YAE03M7JACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8ACTIB
THIAMINE MONONITRATE8K0I04919XACTIB
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
SODIUM FEREDETATE403J23EMFAACTIB
MAGNESIUM OXIDE3A3U0GI71GACTIB
ZINC OXIDESOI2LOH54ZACTIB
CUPRIC OXIDEV1XJQ704R4ACTIB
IRON SUCROSEFZ7NYF5N8LACTIB
IODINE9679TC07X4ACTIB
OMEGA-3 FATTY ACIDS71M78END5SACTIB

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
6c9669f5-7c92-4af0-966a-f4f825fe89abb2f0ca0d-76e9-45f0-bf60-e9781c2276762012-05-01WarningsExact identifier
spl id: 6c9669f5-7c92-4af0-966a-f4f825fe89ab
spl set id: b2f0ca0d-76e9-45f0-bf60-e9781c227676

Reported adverse events (FAERS/openFDA)#

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