Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 46af3f19-055e-4025-a14e-1d6c25880f4d
Route
ORAL
Published
Effective Date 2023-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (6 [hp_X]) Goldenseal (8 [hp_X]) Pulsatilla Pratensis Whole (12 [hp_X]) Solanum Dulcamara Top Strychnos Nux-vomica Seed Ferrosoferric Phosphate Gelsemium Sempervirens Root Dichromate Ion
Inactive Ingredients
Water Alcohol Citric Acid Monohydrate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-05-26

Description

(in each drop) Allium Cepa 6X 12.50%, Hydrastis Canadensis 6X 12.50%, Pulsatilla Pratensis 6X 12.50%, Dulcamara 8x 12.50%, Nux Vomica 8x 12.50%, Ferrum Phosphoricum 12X 12.50%, Gelsemium Sempervirens 12X 12.50%, Kali Bichromicum 12X 12.50%

Purpose

Allium Cepa – runny nose, sore throat,* Hydrastis Canadensis – thick , yellow mucus,* Pulsatilla Pratensis – cough, chills, loss of taste,* Dulcamara – fever with body pains,* Nux Vomica – nausea, stomachache,* Ferrum Phosphoricum – fever, cough,* Gelsemium Sempervirens – weakness, aches,* Kali Bichromicum – yellow expectoration.*


Medication Information

Purpose

Allium Cepa – runny nose, sore throat,* Hydrastis Canadensis – thick , yellow mucus,* Pulsatilla Pratensis – cough, chills, loss of taste,* Dulcamara – fever with body pains,* Nux Vomica – nausea, stomachache,* Ferrum Phosphoricum – fever, cough,* Gelsemium Sempervirens – weakness, aches,* Kali Bichromicum – yellow expectoration.*

Description

(in each drop) Allium Cepa 6X 12.50%, Hydrastis Canadensis 6X 12.50%, Pulsatilla Pratensis 6X 12.50%, Dulcamara 8x 12.50%, Nux Vomica 8x 12.50%, Ferrum Phosphoricum 12X 12.50%, Gelsemium Sempervirens 12X 12.50%, Kali Bichromicum 12X 12.50%

Uses:

May temporariy relieve stuffy and runny nose, coughing, congestion, body aches, fever, weakness, and minor sore throat.*

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

Purposes:

Allium Cepa – runny nose, sore throat,* Hydrastis Canadensis – thick , yellow mucus,* Pulsatilla Pratensis – cough, chills, loss of taste,* Dulcamara – fever with body pains,* Nux Vomica – nausea, stomachache,* Ferrum Phosphoricum – fever, cough,* Gelsemium Sempervirens – weakness, aches,* Kali Bichromicum – yellow expectoration.*

Warnings:

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

Stop use and ask a doctor if symptoms persist for more than 2 days.

For oral use only.  If pregnant or breast-feeding, ask a health care professional before use.

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

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING

Questions:

www.HomeopathyStore.com

(888) 405-7551

Dist. by Ratis, LLC

1201 N Orange St, 

Ste 7594

Wilmington, DE 19801

Directions:

• Adults: 2 sprays 3 times a day or as needed

• Children 3-6: 1 spray as above

• Consult a physician for use in children under 6 years of age.

Store in a cool, dry place

Active Ingredients:

(in each drop) Allium Cepa 6X 12.50%, Hydrastis Canadensis 6X 12.50%, Pulsatilla Pratensis 6X 12.50%, Dulcamara 8x 12.50%, Nux Vomica 8x 12.50%, Ferrum Phosphoricum 12X 12.50%, Gelsemium Sempervirens 12X 12.50%, Kali Bichromicum 12X 12.50%

Inactive Ingredients:

Citric acid, demineralized water, ethanol <0.5%, glycerin.

Package Lable Display:

LACTOSE FREE

ANNA

KARE

Cold Armor

COLD & COUGH RELIEF*

HOMEOPATHIC ORAL SPRAY

1FL. OZ (30ML)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control center right away.


Structured Label Content

Uses: (USES:)

May temporariy relieve stuffy and runny nose, coughing, congestion, body aches, fever, weakness, and minor sore throat.*

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

Purposes: (PURPOSES:)

Allium Cepa – runny nose, sore throat,* Hydrastis Canadensis – thick , yellow mucus,* Pulsatilla Pratensis – cough, chills, loss of taste,* Dulcamara – fever with body pains,* Nux Vomica – nausea, stomachache,* Ferrum Phosphoricum – fever, cough,* Gelsemium Sempervirens – weakness, aches,* Kali Bichromicum – yellow expectoration.*

Warnings: (WARNINGS:)

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

Stop use and ask a doctor if symptoms persist for more than 2 days.

For oral use only.  If pregnant or breast-feeding, ask a health care professional before use.

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

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING

Questions: (QUESTIONS:)

www.HomeopathyStore.com

(888) 405-7551

Dist. by Ratis, LLC

1201 N Orange St, 

Ste 7594

Wilmington, DE 19801

Directions: (DIRECTIONS:)

• Adults: 2 sprays 3 times a day or as needed

• Children 3-6: 1 spray as above

• Consult a physician for use in children under 6 years of age.

Store in a cool, dry place

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) Allium Cepa 6X 12.50%, Hydrastis Canadensis 6X 12.50%, Pulsatilla Pratensis 6X 12.50%, Dulcamara 8x 12.50%, Nux Vomica 8x 12.50%, Ferrum Phosphoricum 12X 12.50%, Gelsemium Sempervirens 12X 12.50%, Kali Bichromicum 12X 12.50%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Citric acid, demineralized water, ethanol <0.5%, glycerin.

Package Lable Display: (PACKAGE LABLE DISPLAY:)

LACTOSE FREE

ANNA

KARE

Cold Armor

COLD & COUGH RELIEF*

HOMEOPATHIC ORAL SPRAY

1FL. OZ (30ML)

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

In case of overdose, get medical help or contact a Poison Control center right away.


Advanced Ingredient Data


Raw Label Data

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