R249

R249
SPL v1
SPL
SPL Set ID 6062a6e8-c570-4099-9256-73db7936f12a
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (1 [hp_X]) Artemisia Annua Flowering Top (2 [hp_X]) Hawthorn Leaf With Flower (3 [hp_X]) Hops (6 [hp_X]) Valerian Bromide Ion Hedeoma Pulegioides Whole Hypericum Perforatum Whole Picric Acid
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Avena sativa 1X Chamomilla 1X Crataegus oxyacantha 1X Humulus lupulus 1X Valeriana officinalis 1X Ammonium bromatum 2X Hedeoma pulegioides 3X Hypericum perforatum 3X Kali bromatum 3X Natrum bromatum 3X Picricum acidum 6X


Medication Information

Description

Avena sativa 1X Chamomilla 1X Crataegus oxyacantha 1X Humulus lupulus 1X Valeriana officinalis 1X Ammonium bromatum 2X Hedeoma pulegioides 3X Hypericum perforatum 3X Kali bromatum 3X Natrum bromatum 3X Picricum acidum 6X

Label

Est 1985

Professional Formulas

Complementary Health

Valeriana Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Section 50565-1

Keep out of the reach of children.

Section 53414-9

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

Section 55105-1

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

In case of overdose, get medical help or contact a poison control center right away.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Indications

For the temporary relief of insomnia, restlessness, or work-related stress.*

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Active Ingredients

Avena sativa 1X

Chamomilla 1X

Crataegus oxyacantha 1X

Humulus lupulus 1X

Valeriana officinalis 1X

Ammonium bromatum 2X

Hedeoma pulegioides 3X

Hypericum perforatum 3X

Kali bromatum 3X

Natrum bromatum 3X

Picricum acidum 6X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Valeriana Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings (WARNINGS)

In case of overdose, get medical help or contact a poison control center right away.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions (DIRECTIONS)

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

For the temporary relief of insomnia, restlessness, or work-related stress.*

Other Information (OTHER INFORMATION)

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Active Ingredients (ACTIVE INGREDIENTS)

Avena sativa 1X

Chamomilla 1X

Crataegus oxyacantha 1X

Humulus lupulus 1X

Valeriana officinalis 1X

Ammonium bromatum 2X

Hedeoma pulegioides 3X

Hypericum perforatum 3X

Kali bromatum 3X

Natrum bromatum 3X

Picricum acidum 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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