Throat Spray

Throat Spray
SPL v1
SPL
SPL Set ID df764380-46e2-46fc-9b5b-a2eca71bbfbf
Route
ORAL
Published
Effective Date 2023-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Baptisia Tinctoria (4 [hp_X]) Phytolacca Americana Root (6 [hp_X]) Goldenseal (12 [hp_X]) Apis Mellifera Silver Cation Atropa Belladonna Calcium Sulfide Dichromate Ion Canis Lupus Familiaris Milk Lachesis Muta Venom Mercurius Solubilis
Inactive Ingredients
Clove Glycerin Althaea Officinalis Root Menthol Myrrh Sage Thyme Rumex Crispus Root Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-04-03

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Baptisia 4X, Phytolacca 4X, Hydrastis 6X, Apis mel 12X, Arg Nit 12X, Belladonna 12X, Hepar Sulph Calc 12X, Kali Bic 12X, Lac Can 12X, Lachesis 12X, Merc Solub 12X


Medication Information

Warnings and Precautions

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Indications and Usage

USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**

Dosage and Administration

DIRECTIONS: Spray 3 to 5 times towards back of the throat as needed or as directed by a health care professional.

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Baptisia 4X, Phytolacca 4X, Hydrastis 6X, Apis mel 12X, Arg Nit 12X, Belladonna 12X, Hepar Sulph Calc 12X, Kali Bic 12X, Lac Can 12X, Lachesis 12X, Merc Solub 12X

Section 34093-5

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

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

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6

INACTIVE INGREDIENTS: Clove Bud, Ethyl Alcohol USP, Glycerin USP, Marshmallow Root, Menthol Crystals, Myrrh Gum, Purified Water, Sage leaves, Thyme Leaves, Yellow Dock Root

Section 51945-4

NDC:43406-0669-2

Throat Spray

HOMEOPATHIC

2 fl oz (60mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1

USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**

Section 55106-9

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Baptisia 4X, Phytolacca 4X, Hydrastis 6X, Apis mel 12X, Arg Nit 12X, Belladonna 12X, Hepar Sulph Calc 12X, Kali Bic 12X, Lac Can 12X, Lachesis 12X, Merc Solub 12X


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**

Dosage and Administration (34068-7)

DIRECTIONS: Spray 3 to 5 times towards back of the throat as needed or as directed by a health care professional.

Warnings and Precautions (34071-1)

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Section 34093-5 (34093-5)

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

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

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Clove Bud, Ethyl Alcohol USP, Glycerin USP, Marshmallow Root, Menthol Crystals, Myrrh Gum, Purified Water, Sage leaves, Thyme Leaves, Yellow Dock Root

Section 51945-4 (51945-4)

NDC:43406-0669-2

Throat Spray

HOMEOPATHIC

2 fl oz (60mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1 (55105-1)

USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Baptisia 4X, Phytolacca 4X, Hydrastis 6X, Apis mel 12X, Arg Nit 12X, Belladonna 12X, Hepar Sulph Calc 12X, Kali Bic 12X, Lac Can 12X, Lachesis 12X, Merc Solub 12X


Advanced Ingredient Data


Raw Label Data

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