Headache Ease

SPL v1

SPL

SPL Set ID bf4a75fd-c315-4885-bae1-52d0007c4ad0

Route

ORAL

Published

Effective Date 2011-08-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Atropa Belladonna (8 [hp_C]) Cyclamen Purpurascens Tuber (4 [hp_C]) Coffee Bean (9 [hp_C]) Iris Versicolor Root Strychnos Nux-vomica Seed Sanguinaria Canadensis Root Spigelia Marilandica Root Viburnum Opulus Bark

Inactive Ingredients

Sucrose Lactose

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2011-08-01

Description

For the temporary relief of migraines, tension and general headaches.

Medication Information

Dosage and Administration

Dissolve 3 pellets directly in mouth 3 times a day or as needed. Twist cap to break seal and release pellets. Let pellets drop directly from cap into mouth. Take away from meals.

Description

For the temporary relief of migraines, tension and general headaches.

Uses:

For the temporary relief of migraines, tension and general headaches.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings:

If symptoms persist or worsen or if pregnant or nursing, consult a doctor. Do not use if cap seal is broken.

Directions:

Active Ingredients:

(HPUS) Belladonna 8C, Cyclamen 8C, Coffea tosta 4C, Iris versicolor 8C, Nux vomica 9C, Sanguinaria 8C, Spigelia 8C, Viburnum opulus 4C

Inactive Ingredients:

Sucrose/lactose

Structured Label Content

Uses:

For the temporary relief of migraines, tension and general headaches.

Dosage and Administration (34068-7)

Dissolve 3 pellets directly in mouth 3 times a day or as needed. Twist cap to break seal and release pellets. Let pellets drop directly from cap into mouth. Take away from meals.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Warnings:

If symptoms persist or worsen or if pregnant or nursing, consult a doctor. Do not use if cap seal is broken.

Directions:

Active Ingredients:

(HPUS) Belladonna 8C, Cyclamen 8C, Coffea tosta 4C, Iris versicolor 8C, Nux vomica 9C, Sanguinaria 8C, Spigelia 8C, Viburnum opulus 4C

Inactive Ingredients:

Sucrose/lactose

Advanced Ingredient Data

[{"name": "ATROPA BELLADONNA", "unii": "WQZ3G9PF0H", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "CYCLAMEN PURPURASCENS TUBER", "unii": "G728143D8Q", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "COFFEE BEAN", "unii": "JFH385Y744", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "IRIS VERSICOLOR ROOT", "unii": "X43D4L3DQC", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "unii": "269XH13919", "classCode": "ACTIB", "strengthNumerator": "9", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "SANGUINARIA CANADENSIS ROOT", "unii": "N9288CD508", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "SPIGELIA MARILANDICA ROOT", "unii": "467D26HS0B", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "VIBURNUM OPULUS BARK", "unii": "T1UG6H6805", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "For the temporary relief of migraines, tension and general headaches.", "34068-7": "Dissolve 3 pellets directly in mouth 3 times a day or as needed. Twist cap to break seal and release pellets. Let pellets drop directly from cap into mouth. Take away from meals.", "50565-1": "Keep out of reach of children.", "Warnings:": "If symptoms persist or worsen or if pregnant or nursing, consult a doctor. Do not use if cap seal is broken.", "Active Ingredients:": "(HPUS) Belladonna 8C, Cyclamen 8C, Coffea tosta 4C, Iris versicolor 8C, Nux vomica 9C, Sanguinaria 8C, Spigelia 8C, Viburnum opulus 4C", "Inactive Ingredients:": "Sucrose/lactose"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:09.056446 · Updated: 2026-03-14T23:14:18.528193