FDA.reportPublic FDA data

Birth Ease

Manufacturer
King Bio, Inc.
Effective date
2012-06-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:03:50

Label at a glance#

ProductBirth Ease
Active ingredientALETRIS FARINOSA ROOT, APIS MELLIFERA, ARNICA MONTANA, ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, MATRICARIA RECUTITA, BLACK COHOSH, IRON, POTASSIUM CARBONATE, JUNIPERUS SABINA LEAFY TWIG, CLAVICEPS PURPUREA SCLEROTIUM, VIBURNUM OPULUS BARK
Label structure8 sections

Indications and uses

Natural assistance for strengthening and toning of the female reproductive system in preparations for birth: tones female organs, for pains during birth, helps to restore the reproductive system after birth. To be taken in the last or 9th month of pregnancy. Reference image: birthease.jpg

Dosage and administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed. Adult Dose - 3 pump sprays Children 2-12 years - 2 pump sprays Reference image: birthease.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Aletris farinosa, Apis mellifica, Arnica montana, Belladonna, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Ferrum metallicum, Kali carbonicum, Sabina, Secale cornutum, Viburnum opulus.


Reference image: birthease.jpg

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

Reference image: birthease.jpg

Purposes

OTC - PURPOSE SECTION

Uses natural assistance for strengthening and toning of the female reproductive system in preparation for birth:

  • tones female organs
  • for pains during birth
  • helps to restore the reproductive system after birth
To be taken in the last or 9th month of pregnancy.

Reference image: birthease.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed.

Adult Dose - 3 pump sprays

Children 2-12 years - 2 pump sprays

Reference image: birthease.jpg

Warnings

WARNINGS SECTION

If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Tamper resistant for your protection. Use only if safety seal is intact.

Reference image: birthease.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Reference image: birthease.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Natural assistance for strengthening and toning of the female reproductive system in preparations for birth: tones female organs, for pains during birth, helps to restore the reproductive system after birth. To be taken in the last or 9th month of pregnancy.

Reference image: birthease.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of labelImage of label

King Bio, Inc.

3 Westside Dr.

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5002-22020-01-31C16284748780-19d75b9d0-6b50-f424-e053-dadaa90a57ceBirth Ease

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5002-2Birth Ease59 mL in 1 BOTTLE, SPRAYLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5002BIRTH EASE (ALETRIS FARINOSA, APIS MELLIFICA, ARNICA MONTANA, BELLADONNA, CAULOPHYLLUM THALICTROIDES, CHAMOMILLA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, KALI CARBONICUM, SABINA, SECALE CORNUTUM, VIBURNUM OPULUS) LIQUID [KING BIO, INC.]2Legacy NDC, 1 package rows20120620_5c254394-b868-4cb8-aa9c-311038dd3176.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALETRIS FARINOSA ROOTACTIVE INGREDIENTO021JGR97X2
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z2
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H2
BLACK COHOSHACTIVE INGREDIENTK73E24S6X92
CAULOPHYLLUM THALICTROIDES ROOTACTIVE INGREDIENTJTJ6HH6YEH2
CLAVICEPS PURPUREA SCLEROTIUMACTIVE INGREDIENT01G9XEA93N2
IRONACTIVE INGREDIENTE1UOL152H72
JUNIPERUS SABINA LEAFY TWIGACTIVE INGREDIENTZ5BEX9K2G12
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ2
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA2
VIBURNUM OPULUS BARKACTIVE INGREDIENTT1UG6H68052
ALETRIS FARINOSA ROOTACTIVE MOIETYO021JGR97X2
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z2
ARNICA MONTANAACTIVE MOIETYO80TY208ZW2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H2
BLACK COHOSHACTIVE MOIETYK73E24S6X92
CAULOPHYLLUM THALICTROIDES ROOTACTIVE MOIETYJTJ6HH6YEH2
CLAVICEPS PURPUREA SCLEROTIUMACTIVE MOIETY01G9XEA93N2
IRONACTIVE MOIETYE1UOL152H72
JUNIPERUS SABINA LEAFY TWIGACTIVE MOIETYZ5BEX9K2G12
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ2
POTASSIUM CATIONACTIVE MOIETY295O53K1522
VIBURNUM OPULUS BARKACTIVE MOIETYT1UG6H68052
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-500257955-5002-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALETRIS FARINOSA ROOTO021JGR97XACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARNICA MONTANAO80TY208ZWACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
BLACK COHOSHK73E24S6X9ACTIB
IRONE1UOL152H7ACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
JUNIPERUS SABINA LEAFY TWIGZ5BEX9K2G1ACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB

Source Document#

Source XML · Source PDF

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
aeddfde6-372e-45aa-b02e-5f5e750a29c65c254394-b868-4cb8-aa9c-311038dd31762012-06-19WarningsExact identifier
spl id: aeddfde6-372e-45aa-b02e-5f5e750a29c6
spl set id: 5c254394-b868-4cb8-aa9c-311038dd3176

Reported adverse events (FAERS/openFDA)#

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