ohm sore throat

ohm sore throat
SPL v4
SPL
SPL Set ID 17d7c802-ed10-4cc9-8261-4f4888004b07
Route
sublingual
Published
Effective Date 2019-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aconitum napellus (7 [hp_X]) ailanthus altissima flowering twig (16 [hp_X]) baptisia tinctoria (3 [hp_X]) atropa belladonna (6 [hp_X]) ferrosoferric phosphate (12 [hp_C]) calcium sulfide (8 [hp_X]) goldenseal mercuric cyanide mercuric iodide phytolacca americana root
Inactive Ingredients
alcohol water glycerin

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2017-04-10

Description

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Aconitum Nap 7X, Ailanthus 16X, Baptisia 3X, Belladonna 7X, Ferrum Phos 6X, Hepar Sulph Calc 12C, Hydrastis 3X, Merc Cyan 16X, Merc Iod Rub 8X, Phytolacca 3X. *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.


Medication Information

Warnings and Precautions

WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomitting may be serious. Consult a physician promptly. Do not use for more than 2 days or administer to children under 3 years of age unless directed by a physician.

Active Ingredient

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Aconitum Nap 7X, Ailanthus 16X, Baptisia 3X, Belladonna 7X, Ferrum Phos 6X, Hepar Sulph Calc 12C, Hydrastis 3X, Merc Cyan 16X, Merc Iod Rub 8X, Phytolacca 3X.

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Indications and Usage

USES: Temporarily relieves symptoms caused by common throat irritation.**

​**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

Dosage and Administration

DIRECTIONS: Shake 10 times before use. Adults & children above 12 years of age: spray 3-4 times under the tongue every 15 minutes, extend intervals as symptoms improve or as directed by a health care professional. Children under 12 years: use half the adult dose.

Description

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Aconitum Nap 7X, Ailanthus 16X, Baptisia 3X, Belladonna 7X, Ferrum Phos 6X, Hepar Sulph Calc 12C, Hydrastis 3X, Merc Cyan 16X, Merc Iod Rub 8X, Phytolacca 3X. *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 50565-1
  • ​KEEP OUT OF REACH OF CHILDREN.
Section 51727-6

INACTIVE INGREDIENTS: Ethanol Alcohol 15% (Non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Purified Water, Vegetable Glycerin 15%.

Section 51945-4

HOMEOPATHIC MEDICINE

NDC: 66096-154-05

SORE THROAT

Natural - Safe - Effective

No Side Effects

2 fl oz (59 mL) / 15% Alcohol

Product of USA

Section 53413-1

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1

Relief from sore throat.

Section 60561-8

Do not use if cap seal is broken.


Structured Label Content

Warnings and Precautions (34071-1)

WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomitting may be serious. Consult a physician promptly. Do not use for more than 2 days or administer to children under 3 years of age unless directed by a physician.

Active Ingredient (55106-9)

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Aconitum Nap 7X, Ailanthus 16X, Baptisia 3X, Belladonna 7X, Ferrum Phos 6X, Hepar Sulph Calc 12C, Hydrastis 3X, Merc Cyan 16X, Merc Iod Rub 8X, Phytolacca 3X.

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Indications and Usage (34067-9)

USES: Temporarily relieves symptoms caused by common throat irritation.**

​**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

Dosage and Administration (34068-7)

DIRECTIONS: Shake 10 times before use. Adults & children above 12 years of age: spray 3-4 times under the tongue every 15 minutes, extend intervals as symptoms improve or as directed by a health care professional. Children under 12 years: use half the adult dose.

Section 50565-1 (50565-1)
  • ​KEEP OUT OF REACH OF CHILDREN.
Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethanol Alcohol 15% (Non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Purified Water, Vegetable Glycerin 15%.

Section 51945-4 (51945-4)

HOMEOPATHIC MEDICINE

NDC: 66096-154-05

SORE THROAT

Natural - Safe - Effective

No Side Effects

2 fl oz (59 mL) / 15% Alcohol

Product of USA

Section 53413-1 (53413-1)

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1 (55105-1)

Relief from sore throat.

Section 60561-8 (60561-8)

Do not use if cap seal is broken.


Advanced Ingredient Data


Raw Label Data

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