SPL v7
SPL
SPL Set ID 828d0f4d-915e-4340-bb98-62cd17eb970b
Route
ORAL
Published
Effective Date 2020-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Agrimonia Eupatoria (3 [hp_X]) Matricaria Chamomilla (12 [hp_X]) Arnica Montana Phosphoric Acid Avena Sativa Flowering Top Strychnos Ignatii Seed Anemone Pulsatilla Aconitum Napellus Strychnos Nux-vomica Seed
Inactive Ingredients
Magnesium Stearate Maltodextrin Lemon Oil Dextrose Monohydrate

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 14 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-05-01

Description

For the temporary relief of occasional stress that affects energy, digestion, nerves and emotions. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.


Medication Information

Description

For the temporary relief of occasional stress that affects energy, digestion, nerves and emotions. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

If symptoms persist more than 7 days or worsen, consult a physician. Keep out of children’s reach.In case of overdose, get medical help or contact a poison control center right away. I f pregnant or breast-feeding, ask a doctor before use.

Do not use if shrink wrap is broken or missing.

Directions

Adults and children over 8: Dissolve one Stress Mints lozenge in mouth. Repeat every half hour as needed.

Indication

For the temporary relief of occasional stress that affects energy, digestion, nerves and emotions. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Inactive Ingredients

Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, Natural and Organic Peppermint Flavors.

4 calories per lozenge. 1 gram sugar per lozenge.

No gluten added. Vegan.

Active Ingredients (hpus)

Aconitum nap 12X, Agrimonia eup 3X, Arnica 12X, Avena 3X, Chamomilla 12X, Chamomilla 30X, Ignatia 12X, Nux vom 12X, Nux vom 30C, Pulsatilla 12X, Pulsatilla, 30C.

Package Label.principal Display Panel


Structured Label Content

Warnings

If symptoms persist more than 7 days or worsen, consult a physician. Keep out of children’s reach.In case of overdose, get medical help or contact a poison control center right away. I f pregnant or breast-feeding, ask a doctor before use.

Do not use if shrink wrap is broken or missing.

Directions

Adults and children over 8: Dissolve one Stress Mints lozenge in mouth. Repeat every half hour as needed.

Indication

For the temporary relief of occasional stress that affects energy, digestion, nerves and emotions. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Inactive Ingredients

Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, Natural and Organic Peppermint Flavors.

4 calories per lozenge. 1 gram sugar per lozenge.

No gluten added. Vegan.

Active Ingredients (hpus) (Active Ingredients (HPUS))

Aconitum nap 12X, Agrimonia eup 3X, Arnica 12X, Avena 3X, Chamomilla 12X, Chamomilla 30X, Ignatia 12X, Nux vom 12X, Nux vom 30C, Pulsatilla 12X, Pulsatilla, 30C.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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