R408

R408
SPL v1
SPL
SPL Set ID a9a7ffcf-03a7-4799-9574-fbbba8a75712
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Amaryllis Belladonna Whole (3 [hp_X]) Artemisia Annua Flowering Top (4 [hp_X]) Gelsemium Sempervirens Root (8 [hp_X]) Solanum Dulcamara Whole (12 [hp_X]) Pulsatilla Montana Whole Oyster Shell Calcium Carbonate, Crude Measles Virus Histatin 3 Draba Verna Whole Human Varicella-zoster Immune Globulin
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Belladonna 3X Chamomilla 3X Gelsemium sempervirens 3X Dulcamara 4X Pulsatilla 4X Calcarea carbonica 8X Morbillinum 12X Parotitis 12X Rubella 12X Varicella 12X


Medication Information

Description

Belladonna 3X Chamomilla 3X Gelsemium sempervirens 3X Dulcamara 4X Pulsatilla 4X Calcarea carbonica 8X Morbillinum 12X Parotitis 12X Rubella 12X Varicella 12X

Label

Est 1985

Professional Formulas

Complementary Health

Childhood Diseases Nosode 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

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

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 to 15 drops once weekly or monthly. If mild symptoms are present, 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 occasional headache, fatigue, cough, runny nose, or minor sore throat.*

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

Belladonna 3X

Chamomilla 3X

Gelsemium sempervirens 3X

Dulcamara 4X

Pulsatilla 4X

Calcarea carbonica 8X

Morbillinum 12X

Parotitis 12X

Rubella 12X

Varicella 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Childhood Diseases Nosode 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)

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, rash, or persistent headache, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

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 to 15 drops once weekly or monthly. If mild symptoms are present, 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 occasional headache, fatigue, cough, runny nose, or minor sore throat.*

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)

Belladonna 3X

Chamomilla 3X

Gelsemium sempervirens 3X

Dulcamara 4X

Pulsatilla 4X

Calcarea carbonica 8X

Morbillinum 12X

Parotitis 12X

Rubella 12X

Varicella 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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