R213

R213
SPL v1
SPL
SPL Set ID 83dc0667-1ed6-4b08-95c3-28d2021988cf
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hawthorn Leaf With Flower (2 [hp_X]) Selenicereus Grandiflorus Stem (3 [hp_X]) Carbonate Ion (6 [hp_X]) Spigelia Anthelmia Whole Nitroglycerin
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Crataegus oxyacantha 2X Cactus grandiflorus 3X Kali carbonicum 3X Spigelia anthelmia 3X Glonoinum 6X


Medication Information

Description

Crataegus oxyacantha 2X Cactus grandiflorus 3X Kali carbonicum 3X Spigelia anthelmia 3X Glonoinum 6X

Label

Est 1985

Professional Formulas

Complementary Health

Cactus 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

Seek medical attention immediately for severe symptoms such as chest pressure or tightness with radiation of the pain to the jaw and down the arm, shortness of breath, or sweating. 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 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 muscle cramps or spasms, mild abdominal or chest pain, or anxiousness.*

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

Crataegus oxyacantha 2X

Cactus grandiflorus 3X

Kali carbonicum 3X

Spigelia anthelmia 3X

Glonoinum 6X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Cactus 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)

Seek medical attention immediately for severe symptoms such as chest pressure or tightness with radiation of the pain to the jaw and down the arm, shortness of breath, or sweating. 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 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 muscle cramps or spasms, mild abdominal or chest pain, or anxiousness.*

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)

Crataegus oxyacantha 2X

Cactus grandiflorus 3X

Kali carbonicum 3X

Spigelia anthelmia 3X

Glonoinum 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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