FDA.reportPublic FDA data

Bio-Combination 12

Manufacturer
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | Rxhomeo, Inc
Effective date
2016-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:44

Label at a glance#

ProductBio-Combination 12
Active ingredientFERROSOFERRIC PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CHLORIDE
Label structure9 sections

Indications and uses

Headache

Storage and handling

Store in a cool dark place

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

FERRUM PHOSPHORICUM 12X HPUS, KALI PHOSPHORICUM 3X HPUS, MAGNESIA PHOSPHORICA 3X HPUS, NATRUM MURIATICUM 6X HPUS

USES

OTC - PURPOSE SECTION

Headache

INDICATIONS

INDICATIONS & USAGE SECTION

Condition listed above or as directed by the physician

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Adults- Take 4 or 6 tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

WARNINGS

WARNINGS SECTION

This product is to be used for self-limiting conditions.

OTC - STOP USE SECTION

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children

OTC - DO NOT USE SECTION

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose

STORAGE

STORAGE AND HANDLING SECTION

Store in a cool dark place

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

www.rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
15631-2367-02020-01-31C16284748780-19d75b9d0-fb6b-f424-e053-dadaa90a57ce1497c7be-59c6-4125-ae38-1a2c4d4f80d2
15631-2367-12020-01-31C16284748780-19d75b9d0-fb6b-f424-e053-dadaa90a57ce1497c7be-59c6-4125-ae38-1a2c4d4f80d2
15631-2367-22020-01-31C16284748780-19d75b9d0-fb6b-f424-e053-dadaa90a57ce1497c7be-59c6-4125-ae38-1a2c4d4f80d2
15631-2367-32020-01-31C16284748780-19d75b9d0-fb6b-f424-e053-dadaa90a57ce1497c7be-59c6-4125-ae38-1a2c4d4f80d2
15631-2367-42020-01-31C16284748780-19d75b9d0-fb6b-f424-e053-dadaa90a57ce1497c7be-59c6-4125-ae38-1a2c4d4f80d2
15631-2367-52020-01-31C16284748780-19d75b9d0-fb6b-f424-e053-dadaa90a57ce1497c7be-59c6-4125-ae38-1a2c4d4f80d2
15631-2367-62020-01-31C16284748780-19d75b9d0-fb6b-f424-e053-dadaa90a57ce1497c7be-59c6-4125-ae38-1a2c4d4f80d2
15631-2367-72020-01-31C16284748780-19d75b9d0-fb6b-f424-e053-dadaa90a57ce1497c7be-59c6-4125-ae38-1a2c4d4f80d2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-2367-0Bio-Combination 121 in 1 BLISTER PACKTABLET12
15631-2367-1Bio-Combination 124 in 1 BLISTER PACKTABLET42
15631-2367-2Bio-Combination 1250 in 1 CONTAINERTABLET502
15631-2367-3Bio-Combination 12100 in 1 CONTAINERTABLET1002
15631-2367-4Bio-Combination 12250 in 1 CONTAINERTABLET2502
15631-2367-5Bio-Combination 12500 in 1 CONTAINERTABLET5002
15631-2367-6Bio-Combination 121000 in 1 CONTAINERTABLET10002
15631-2367-7Bio-Combination 1210000 in 1 CONTAINERTABLET100002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-2367BIO-COMBINATION 12 (FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM) TABLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2Legacy NDC, 8 package rows20160412_1497c7be-59c6-4125-ae38-1a2c4d4f80d2.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15631-236715631-2367-0, 15631-2367-1, 15631-2367-2, 15631-2367-3, 15631-2367-4, 15631-2367-5, 15631-2367-6, 15631-2367-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
LACTOSEJ2B2A4N98GIACT

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
36dea673-c024-40a7-a4f8-3bbdfd2f78da1497c7be-59c6-4125-ae38-1a2c4d4f80d22016-04-11WarningsExact identifier
spl id: 36dea673-c024-40a7-a4f8-3bbdfd2f78da
spl set id: 1497c7be-59c6-4125-ae38-1a2c4d4f80d2

Reported adverse events (FAERS/openFDA)#

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