Nasal Decongestant

Nasal Decongestant
SPL v1
SPL
SPL Set ID 938a25f8-e854-4537-a04d-5e2276199f5c
Route
ORAL
Published
Effective Date 2023-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camellia Sinensis Whole (4 [hp_X]) Ephedra Distachya Flowering Twig (12 [hp_X]) Atropa Belladonna (30 [hp_X]) Arsenic Cation (3+) Mercuric Cation Dichromate Ion Anemone Pulsatilla Sepia Officinalis Juice Oyster Shell Calcium Carbonate, Crude Mercurius Solubilis Sulfur
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-06-13

Description

ACTIVE INGREDIENTS - equal amounts of: Camellia Sinensis 4X, Ephedra Vulgaris 4X, Belladonna 4X, Arsenicum Album 12X, Cinnabaris 12X, Kali Bichromicum 12X, Pulsatilla 12X, Sepia 12X, Calcarea Carbonica 30X, Mercurius Solubilis 30X, Sulphur 30X


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.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Indications and Usage

USES: Temporary relief of nasal congestion.**

Dosage and Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Description

ACTIVE INGREDIENTS - equal amounts of: Camellia Sinensis 4X, Ephedra Vulgaris 4X, Belladonna 4X, Arsenicum Album 12X, Cinnabaris 12X, Kali Bichromicum 12X, Pulsatilla 12X, Sepia 12X, Calcarea Carbonica 30X, Mercurius Solubilis 30X, Sulphur 30X

Section 34093-5

**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: Ethyl Alcohol USP, Purified Water

Section 51945-4

NDC:43406-0693-1

Nasal Decongestant

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

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

Section 55105-1

USES: Temporary relief of nasal congestion.**

Section 55106-9

ACTIVE INGREDIENTS - equal amounts of: Camellia Sinensis 4X, Ephedra Vulgaris 4X, Belladonna 4X, Arsenicum Album 12X, Cinnabaris 12X, Kali Bichromicum 12X, Pulsatilla 12X, Sepia 12X, Calcarea Carbonica 30X, Mercurius Solubilis 30X, Sulphur 30X


Structured Label Content

Indications and Usage (34067-9)

USES: Temporary relief of nasal congestion.**

Dosage and Administration (34068-7)

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, 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.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Section 34093-5 (34093-5)

**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: Ethyl Alcohol USP, Purified Water

Section 51945-4 (51945-4)

NDC:43406-0693-1

Nasal Decongestant

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

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

Section 55105-1 (55105-1)

USES: Temporary relief of nasal congestion.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS - equal amounts of: Camellia Sinensis 4X, Ephedra Vulgaris 4X, Belladonna 4X, Arsenicum Album 12X, Cinnabaris 12X, Kali Bichromicum 12X, Pulsatilla 12X, Sepia 12X, Calcarea Carbonica 30X, Mercurius Solubilis 30X, Sulphur 30X


Advanced Ingredient Data


Raw Label Data

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