drug facts

drug facts
SPL v1
SPL
SPL Set ID 1673dae8-7ab7-450e-bdb2-bedb50356b74
Route
oral
Published
Effective Date 2017-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
helianthemum nummularium flower (5 [hp_X]) impatiens glandulifera flower olea europaea flower ornithogalum umbellatum flowering top prunus cerasifera flower
Inactive Ingredients
sucrose lactose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
unapproved homeopathic active Since 2016-05-13

Description

HELIANTHEMUM NUM, FLOS IMPATIENS GLAN, FLOS OLEA EUR, FLOS ORNITHOGALUM UMBELLATUM, FLOS PRUNUS CERA, FLOS


Medication Information

Uses

Temporarily relieves pain and other symptoms associated with insect bites and stings, including mosquito, ant, bee, and wasp.

Directions

Adults: 2 pills every 3 hours for 2 days. Then 2 pills morning and night for 2 weeks.

Children: 1 pill. Repeat as necessary.

Inactive Ingredients

Sucrose/Lactose Pills

Description

HELIANTHEMUM NUM, FLOS IMPATIENS GLAN, FLOS OLEA EUR, FLOS ORNITHOGALUM UMBELLATUM, FLOS PRUNUS CERA, FLOS

Principal Display Panel

Indications

Indications:

Helianthemum num, flos 5x (Rock Rose) –acute anxiety*

Impatiens glan, flos 5x (Impatiens) –impatience*

Olea eur, flos 5x (Olive) –mental fatigue*

Ornithogalum umbellatum, flos 5x (Star of Bethlehem) –after effects of shock*

Prunus cera, flos 5x (Cherry Plum) –desperation

■ Fear and worrying ■ Impatience ■ Feeling overwhelmed ■ Stage fright

*These statements have not been reviewed by the Food and Drug Administration.

Active Ingredients

HELIANTHEMUM NUM, FLOS

IMPATIENS GLAN, FLOS

OLEA EUR, FLOS

ORNITHOGALUM UMBELLATUM, FLOS

PRUNUS CERA, FLOS

Stop Use and Ask Doctor

If symptoms persist or recur, discontinue use. If pregnant or nursing a baby, consult a licensed practitioner before using this product.

Keep Out of Reach of Children

As wtih all medications, keep out of reach of children.


Structured Label Content

Uses (USES)

Temporarily relieves pain and other symptoms associated with insect bites and stings, including mosquito, ant, bee, and wasp.

Directions (DIRECTIONS)

Adults: 2 pills every 3 hours for 2 days. Then 2 pills morning and night for 2 weeks.

Children: 1 pill. Repeat as necessary.

Inactive Ingredients (INACTIVE INGREDIENTS)

Sucrose/Lactose Pills

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Indications (INDICATIONS)

Indications:

Helianthemum num, flos 5x (Rock Rose) –acute anxiety*

Impatiens glan, flos 5x (Impatiens) –impatience*

Olea eur, flos 5x (Olive) –mental fatigue*

Ornithogalum umbellatum, flos 5x (Star of Bethlehem) –after effects of shock*

Prunus cera, flos 5x (Cherry Plum) –desperation

■ Fear and worrying ■ Impatience ■ Feeling overwhelmed ■ Stage fright

*These statements have not been reviewed by the Food and Drug Administration.

Active Ingredients (ACTIVE INGREDIENTS)

HELIANTHEMUM NUM, FLOS

IMPATIENS GLAN, FLOS

OLEA EUR, FLOS

ORNITHOGALUM UMBELLATUM, FLOS

PRUNUS CERA, FLOS

Stop Use and Ask Doctor (STOP USE AND ASK DOCTOR)

If symptoms persist or recur, discontinue use. If pregnant or nursing a baby, consult a licensed practitioner before using this product.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

As wtih all medications, keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)