Reaphirm Plant Source DHA

Manufacturer
Everett Laboratories, Inc.
Effective date
2011-11-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:13:23

Label at a glance#

ProductReaphirm Plant Source DHA
Active ingredientVitamin A, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Iodine, Magnesium, Zinc, Copper, Vitamin D, Omega-3 Fatty Acids, Vitamin E, Iron
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 the reach of children.  In case of accidental overdose, call a doctor or a Poison Control Center immediately.

Dosage and administration

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

Label contents#

Full prescribing information#

Contraindications

CONTRAINDICATIONS SECTION

Reaphirm Plant Source DHA is contraindicated in patients with hypersensitivity to any of its components or color additives.

Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

Iron Therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).

Refer to MM1carton label

Boxed Warning

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 the reach of children.  In case of accidental overdose, call a doctor or a Poison Control Center immediately.

WARNINGS/PRECAUTIONS:

WARNINGS AND PRECAUTIONS SECTION

Reaphirm Plant Source DHA should be used with caution in patients with known sensitivity or allergy to soy.

Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kigney stones.  High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues.  Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.

Iodine should be used with caution in patients with an overactive thyroid.

Prolonged use of iron salts may produce iron storage disease.

Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.

Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.  Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.

Avoid Overdosage.  Keep out of the reach of children.

Drug Interactions:

Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.

Medications for hypertension used in conjunction with iodine supplementation may increase potassium.

High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.

Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.

Consult appropriate references for additional specific vitamin-drug interactions.

Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

Pediatric Use: Not for pediatric use. 


Adverse Reactions

ADVERSE REACTIONS SECTION

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Reaphirm Plant Source DHA.  Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

How Supplied

HOW SUPPLIED SECTION

Reaphirm Plant Source DHA is available as a dark blue, oval shaped softgel capsule imprinted "EV3010".  Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules).

Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat.

Rx Only

Manufactured for

EVERETT LABORATORIES, INC.


West Orange, NJ 07052

1-877-324-9349

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

reaphirm111128carton_lcr

reaphirm111128carton_lcr
reaphirm111128carton_lcr

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
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910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
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ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
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0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
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6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0642-3010-302020-01-31C16284748780-19d75b9d1-080a-f424-e053-dadaa90a57ceProduct Information.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0642-3010-30Reaphirm Plant Source DHA5 in 1 BOXCAPSULE, GELATIN COATED51
0642-3010-30Reaphirm Plant Source DHA6 in 1 BLISTER PACKCAPSULE, GELATIN COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0642-3010REAPHIRM PLANT SOURCE DHA (PRENATAL SUPPLEMENT) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]1Legacy NDC, 2 package rows20111205_8896031e-7cb4-4376-84b1-97eae5015ec4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0642-3010-30EA - Each0642-301070f70393-81d2-4a80-aa32-9fbb2df095f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0R1
CopperACTIVE INGREDIENT789U1901C51
CyanocobalaminACTIVE INGREDIENTP6YC3EG2041
Folic AcidACTIVE INGREDIENT935E97BOY81
IodineACTIVE INGREDIENT9679TC07X41
IronACTIVE INGREDIENTE1UOL152H71
MagnesiumACTIVE INGREDIENTI38ZP9992A1
NiacinACTIVE INGREDIENT2679MF687A1
Omega-3 Fatty AcidsACTIVE INGREDIENT71M78END5S1
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV1
RiboflavinACTIVE INGREDIENTTLM2976OFR1
Thiamine MononitrateACTIVE INGREDIENT8K0I04919X1
Vitamin AACTIVE INGREDIENT81G40H8B0T1
Vitamin DACTIVE INGREDIENT9VU1KI44GP1
Vitamin EACTIVE INGREDIENTH4N855PNZ11
ZincACTIVE INGREDIENTJ41CSQ7QDS1
Alpha-TocopherolACTIVE MOIETYH4N855PNZ11
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R1
Beta CaroteneACTIVE MOIETY01YAE03M7J1
CholecalciferolACTIVE MOIETY1C6V77QF411
Cupric OxideACTIVE MOIETYV1XJQ704R41
CyanocobalaminACTIVE MOIETYP6YC3EG2041
DoconexentACTIVE MOIETYZAD9OKH9JC1
Folic AcidACTIVE MOIETY935E97BOY81
IodineACTIVE MOIETY9679TC07X41
IronACTIVE MOIETYE1UOL152H71
Magnesium OxideACTIVE MOIETY3A3U0GI71G1
NiacinamideACTIVE MOIETY25X51I8RD41
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1
RiboflavinACTIVE MOIETYTLM2976OFR1
ThiamineACTIVE MOIETYX66NSO3N351
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Anhydrous Dibasic Calcium PhosphateINACTIVE INGREDIENTL11K75P92J1
Ascorbyl palmitateINACTIVE INGREDIENTQN83US2B0N1
CaramelINACTIVE INGREDIENTT9D99G2B1R1
Corn OilINACTIVE INGREDIENT8470G57WFM1
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBD1
GelatinINACTIVE INGREDIENT2G86QN327L1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM621
Sodium ThiosulfateINACTIVE INGREDIENTHX1032V43M1
SorbitolINACTIVE INGREDIENT506T60A25R1
Soybean OilINACTIVE INGREDIENT241ATL177A1
Sunflower OilINACTIVE INGREDIENT3W1JG795YI1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
TocopherolINACTIVE INGREDIENTR0ZB2556P81
WaterINACTIVE INGREDIENT059QF0KO0R1
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0642-30100642-3010-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 319 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GelatinGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
Anhydrous Dibasic Calcium PhosphateANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCREAM / TOPICAL36 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
FD&C Blue NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
Ascorbyl palmitateASCORBYL PALMITATEQN83US2B0NCAPSULE / ORAL12 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium ThiosulfateSODIUM THIOSULFATEHX1032V43MSUSPENSION/ DROPS / OPHTHALMIC3.15 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
FD&C Blue NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
11 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C Blue NO. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Anhydrous Dibasic Calcium PhosphateANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JCAPSULE / ORAL401 mgExact identifier — unii candidate
15 equally ranked IID candidates
GelatinGELATIN2G86QN327LPOWDER / RESPIRATORY (INHALATION)100 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, SOLUTION / INTRAVENOUS4050 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GelatinGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
TocopherolTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates

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
37359587-129b-461f-a82f-b4461eeff0808896031e-7cb4-4376-84b1-97eae5015ec42011-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 37359587-129b-461f-a82f-b4461eeff080
spl set id: 8896031e-7cb4-4376-84b1-97eae5015ec4

Reported adverse events (FAERS/openFDA)#

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