X34

X34
SPL v1
SPL
SPL Set ID 38f2ae0b-2b1f-4b49-934d-fe1556f84d93
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspartame (6 [hp_X]) Saccharin (30 [hp_X]) Sucralose Cyclamic Acid
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Aspartame 6X, 12X, 30X, 60X, 100X Saccharin 6X, 12X, 30X, 60X, 100X Sucralose 6X, 12X, 30X, 60X, 100X Sodium cyclamate 30X, 60X, 100X


Medication Information

Description

Aspartame 6X, 12X, 30X, 60X, 100X Saccharin 6X, 12X, 30X, 60X, 100X Sucralose 6X, 12X, 30X, 60X, 100X Sodium cyclamate 30X, 60X, 100X

Label

Est 1985

Professional Formulas

Complementary Health

Artificial Sweetener Detox

Homeopathic Remedy

2 FL. OZ. (59 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

Consult a doctor if condition worsens or symptoms persist. 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 occasional headache, bloating, nausea or vomiting, diarrhea, difficulty breathing, cough, runny nose, skin irritation, itchy eyes, or irritability due to sensitivity to or exposure to artificial sweeteners.*

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

Aspartame 6X, 12X, 30X, 60X, 100X

Saccharin 6X, 12X, 30X, 60X, 100X

Sucralose 6X, 12X, 30X, 60X, 100X

Sodium cyclamate 30X, 60X, 100X

Inactive Ingredients

20% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Artificial Sweetener Detox

Homeopathic Remedy

2 FL. OZ. (59 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)

Consult a doctor if condition worsens or symptoms persist. 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 occasional headache, bloating, nausea or vomiting, diarrhea, difficulty breathing, cough, runny nose, skin irritation, itchy eyes, or irritability due to sensitivity to or exposure to artificial sweeteners.*

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)

Aspartame 6X, 12X, 30X, 60X, 100X

Saccharin 6X, 12X, 30X, 60X, 100X

Sucralose 6X, 12X, 30X, 60X, 100X

Sodium cyclamate 30X, 60X, 100X

Inactive Ingredients (INACTIVE INGREDIENTS)

20% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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