ALLIUM CEPA PLEX- allium cepa, belladonna, euphrasia officinalis, hydrastis canadensis, kali bichromicum, mercurius dulcis, sambucus nigra liquid

ALLIUM CEPA PLEX by

Drug Labeling and Warnings

ALLIUM CEPA PLEX by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Each drop contains:

Allium cepa (Onion) Bulb 6X
Belladonna (Deadly nightshade) Whole Plant 6X (<1.43 x 10-8 % alkaloids, calculated)
Euphrasia officinalis (Eyebright) Whole Plant 6X
Hydrastis canadensis (Golden seal) Underground Parts 6X
Kali bichromicum (Potassium bichromate) 6X
Mercurius dulcis (Calomel) 6X
Sambucus nigra (European elder) Leaves and Inflorescences 6X

PURPOSE

Uses

For the temporary relief of nasal congestion and watery eyes due to colds and allergies.

WARNINGS

Warnings
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if symptoms persist or worsen.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Inactive ingredients
Ethanol (beet), purified water

OTHER SAFETY INFORMATION

Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.

Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.

DOSAGE & ADMINISTRATION

Directions

To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

Adults and adolescents (12 years and older)

Take 10 drops three times daily or as recommended by your healthcare practitioner.

Children (under 12 years)

Take under the direction of your healthcare practitioner.

INDICATIONS & USAGE

Uses

For the temporary relief of nasal congestion and watery eyes due to colds and allergies.

Directions

To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

Adults and adolescents (12 years and older)

Take 10 drops three times daily or as recommended by your healthcare practitioner.

Children (under 12 years)

Take under the direction of your healthcare practitioner.

PRINCIPAL DISPLAY PANEL

NDC: 62106-1192-0

UNDA

plex

ALLIUM CEPA PLEX

Homeopathic Preparation

For the temporary relief of nasal congestion

and watery eyes due to colds and allergies.

Contains 30% Alcohol
1 fl oz (30 mL)

INGREDIENTS AND APPEARANCE

ALLIUM CEPA PLEX 
allium cepa, belladonna, euphrasia officinalis, hydrastis canadensis, kali bichromicum, mercurius dulcis, sambucus nigra liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-1192
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 30 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 30 mL
ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J)	ATROPA BELLADONNA WHOLE	6 [hp_X]  in 30 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 30 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_X]  in 30 mL
CALOMEL (UNII: J2D46N657D) (CALOMEL - UNII:J2D46N657D)	CALOMEL	6 [hp_X]  in 30 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	6 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-1192-0	1 in 1 CARTON	12/15/2015
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/15/2015

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-1192)