Rolfia Tablets

Manufacturer: Adven Biotech Private Limited
Effective date: 2016-04-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:07:40

Label at a glance#

Productrolfia

Active ingredientPOTASSIUM BROMIDE, CRATAEGUS MONOGYNA LEAF, PASSIFLORA INCARNATA ROOT, RAUWOLFIA SERPENTINA

Label structure8 sections

Indications and uses

Normalizes high blood pressure, conrols hypertension, tones up the heart muscle, treats arteriosclerosis and related symptoms like sleeplessness, irritability.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Crataegus Oxyacantha, Passiflora Incarnata, Rauwolfia Serpentina, Kali Bromatum

DOSAGE & ADMINISTRATION SECTION

Adults: Take 2 tablets with water every 8 hours.

Children under 18 years: Please consult physician.

Warnings:

WARNINGS SECTION

If symptons persist or worsen, a physician should be consulted. Keep out of reach of children. Do not use, if known sentivity to any of its ingredients exists. Replace cap tightly. If pregnant or breast feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - PURPOSE SECTION

Tones up the Heart Muscle, Controls hypertension. Decrease Blood Pressure

Uses:

INDICATIONS & USAGE SECTION

Normalizes high blood pressure, conrols hypertension, tones up the heart muscle, treats arteriosclerosis and related symptoms like sleeplessness, irritability.

INACTIVE INGREDIENT SECTION

Sugar of milk

OTC - DO NOT USE SECTION

Do not use if neck wrap or foil inner seal is broken or missing. Protect from moisture, direct sunlight and heat.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rolfia tablets label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69825-007-02	2020-01-31	C162847	48780-1	9d75b9d0-4b61-f424-e053-dadaa90a57ce	Rolfia Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69825-007-01	rolfia	100 g in 1 BOTTLE	TABLET	100		1
69825-007-02	rolfia	1 in 1 BOX	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69825-007	ROLFIA (CRATAEGUS OXY, PASSIFLORE INC, RAUWOLFIA SER, KALI BROM) TABLET [ADVEN BIOTECH PRIVATE LIMITED]	1	Legacy NDC, 2 package rows	20160402_2f74679b-c610-229f-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

rolfia
Crataegus Oxy, Passiflore Inc, Rauwolfia Ser, Kali Brom
POTASSIUM BROMIDE
BROMIDE ION
CRATAEGUS MONOGYNA LEAF
PASSIFLORA INCARNATA ROOT
RAUWOLFIA SERPENTINA
LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69825-007	69825-007-01, 69825-007-02

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
Name	UNII	Kind
POTASSIUM BROMIDE	OSD78555ZM	ACTIB
CRATAEGUS MONOGYNA LEAF	A2KER9748T	ACTIB
PASSIFLORA INCARNATA ROOT	3952I8DXEX	ACTIB
RAUWOLFIA SERPENTINA	H192N84N1G	ACTIB
LACTOSE	J2B2A4N98G	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2f74679b-c611-229f-e054-00144ff88e88			2f74679b-c610-229f-e054-00144ff88e88	2016-04-01	Warnings	Exact identifier spl id: 2f74679b-c611-229f-e054-00144ff88e88 spl set id: 2f74679b-c610-229f-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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