Rolfia (Crataegus Oxy, Passiflore Inc, Rauwolfia Ser, Kali Brom) Tablet [Adven Biotech Private Limited] -

ROLFIA (CRATAEGUS OXY, PASSIFLORE INC, RAUWOLFIA SER, KALI BROM) TABLET [ADVEN BIOTECH PRIVATE LIMITED]
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NDC	69825-007-01, 69825-007-02
Set ID	2f74679b-c610-229f-e054-00144ff88e88
Category	HUMAN OTC DRUG LABEL
Packager	Adven Biotech Private Limited
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENT

Crataegus Oxyacantha, Passiflora Incarnata, Rauwolfia Serpentina, Kali Bromatum
DOSAGE & ADMINISTRATION

Adults: Take 2 tablets with water every 8 hours.

Children under 18 years: Please consult physician.
Warnings:

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.
PURPOSE

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

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

Sugar of milk
DO NOT USE

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

INGREDIENTS AND APPEARANCE

ROLFIA
crataegus oxy, passiflore inc, rauwolfia ser, kali brom tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	3 [hp_X] in 100 g
CRATAEGUS MONOGYNA LEAF (UNII: A2KER9748T) (CRATAEGUS MONOGYNA LEAF - UNII:A2KER9748T)	CRATAEGUS MONOGYNA LEAF	2 [hp_X] in 100 g
PASSIFLORA INCARNATA ROOT (UNII: 3952I8DXEX) (PASSIFLORA INCARNATA ROOT - UNII:3952I8DXEX)	PASSIFLORA INCARNATA ROOT	2 [hp_X] in 100 g
RAUWOLFIA SERPENTINA (UNII: H192N84N1G) (RAUWOLFIA SERPENTINA - UNII:H192N84N1G)	RAUWOLFIA SERPENTINA	2 [hp_X] in 100 g

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69825-007-02	1 in 1 BOX	03/30/2016
1	NDC:69825-007-01	100 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/30/2016

Labeler - Adven Biotech Private Limited (858029164)

Name	Address	ID/FEI	Business Operations
Establishment
Adven Biotech Private Limited		858029164	manufacture(69825-007) , relabel(69825-007) , repack(69825-007)

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