drug facts:

drug facts:
SPL v2
SPL
SPL Set ID 6d49b251-bc9a-4383-a538-91d923e89148
Route
oral
Published
Effective Date 2024-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aconitum napellus (200 [hp_C]) milk thistle (3 [hp_X]) arabica coffee bean (2 [hp_X]) dioscorea villosa root (12 [hp_X]) gelsemium sempervirens root pseudognaphalium obtusifolium iris versicolor root passiflora incarnata flowering top stellaria media verbascum thapsus
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic completed Since 2024-07-30 Until 2027-11-21

Purpose

May temporarily relieve symptoms of tension headaches: • dull or sharp pain • neck and shoulder tension • feelings of pressure** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each spray) 10% of Aconitum Napellus 200C, Carduus Marianus 3X, Coffea Cruda 200C, Dioscorea Villosa 3X, Gelsemium Sempervirens 3X, Gnaphalium Polycephalum 3X, Iris Versicolor 3X, Passiflora Incarnata 2X, Stellaria Media 3X, Verbascum Thapsus 12X.


Medication Information

Purpose

May temporarily relieve symptoms of tension headaches: • dull or sharp pain • neck and shoulder tension • feelings of pressure** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each spray) 10% of Aconitum Napellus 200C, Carduus Marianus 3X, Coffea Cruda 200C, Dioscorea Villosa 3X, Gelsemium Sempervirens 3X, Gnaphalium Polycephalum 3X, Iris Versicolor 3X, Passiflora Incarnata 2X, Stellaria Media 3X, Verbascum Thapsus 12X.

Uses:

May temporarily relieve symptoms of tension headaches:

• dull or sharp pain

• neck and shoulder tension

• feelings of pressure**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose:

May temporarily relieve symptoms of tension headaches:

• dull or sharp pain

• neck and shoulder tension

• feelings of pressure**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

If pregnant or breast feeding, ask a doctor before using product.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Store at room temperature.

Questions:

DIST. BY

LIDDELL LABORATORIES, INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

Directions:

Adults and children over 12: Spray twice under the tongue up to each 30 minutes as needed.

Children 12 and under: Consult a doctor prior to use.

Active Ingredients:

(in each spray) 10% of Aconitum Napellus 200C, Carduus Marianus 3X, Coffea Cruda 200C, Dioscorea Villosa 3X, Gelsemium Sempervirens 3X, Gnaphalium Polycephalum 3X, Iris Versicolor 3X, Passiflora Incarnata 2X, Stellaria Media 3X, Verbascum Thapsus 12X.

Inactive Ingredients:

Organic alcohol 20% v/v, Purified water.

Package Label Display:

ORAL SPRAYS

LIDDELL ®

LABORATORIES

EST. 1994

42 TH

Tension Headache

HOMEOPATHIC

1.0 FL OZ (30 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or call a Poison Control Center right away.


Structured Label Content

Uses: (USES:)

May temporarily relieve symptoms of tension headaches:

• dull or sharp pain

• neck and shoulder tension

• feelings of pressure**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose: (PURPOSE:)

May temporarily relieve symptoms of tension headaches:

• dull or sharp pain

• neck and shoulder tension

• feelings of pressure**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

If pregnant or breast feeding, ask a doctor before using product.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Store at room temperature.

Questions: (QUESTIONS:)

DIST. BY

LIDDELL LABORATORIES, INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

Directions: (DIRECTIONS:)

Adults and children over 12: Spray twice under the tongue up to each 30 minutes as needed.

Children 12 and under: Consult a doctor prior to use.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each spray) 10% of Aconitum Napellus 200C, Carduus Marianus 3X, Coffea Cruda 200C, Dioscorea Villosa 3X, Gelsemium Sempervirens 3X, Gnaphalium Polycephalum 3X, Iris Versicolor 3X, Passiflora Incarnata 2X, Stellaria Media 3X, Verbascum Thapsus 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Organic alcohol 20% v/v, Purified water.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ORAL SPRAYS

LIDDELL ®

LABORATORIES

EST. 1994

42 TH

Tension Headache

HOMEOPATHIC

1.0 FL OZ (30 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or call a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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