Cough Syrup

Cough Syrup
SPL v3
SPL
SPL Set ID 285230d6-96b7-4bab-8347-c7b10a3c0ebb
Route
ORAL
Published
Effective Date 2022-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (30 [hp_C]) Arsenic Cation (3+) Bryonia Alba Root Drosera Rotundifolia Ipecac Carbonate Ion Phosphorus Anemone Pulsatilla Spongia Officinalis Skeleton, Roasted Drimia Maritima Whole
Inactive Ingredients
Acacia Anise Oil Citric Acid Monohydrate Eucalyptus Oil Glycerin Chamomile Echinacea Angustifolia Cetraria Islandica Subsp. Islandica Althaea Officinalis Root Mullein Leaf Musa X Paradisiaca Leaf Red Clover Urtica Dioica Leaf Thyme Honey Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-05-07

Description

ACTIVE INGREDIENTS (HPUS*): Camphora 3X, 30C, Arsenicum Album 30C, Bryonia Alba 30C, Drosera Rotundifolia 30C, Ipecacuanha 30C, Kali Carbonicum 30C, Phosphorus 30C, Pulsatilla 30C, Spongia Tosta 30C, Squilla Maritima 30C.


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 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: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

Dosage and Administration

DIRECTIONS: Adults & children above 4 years: 1 teaspoon (5mL) every 2-3 hours, or as directed by a health care professional. Shake well before use.

Description

ACTIVE INGREDIENTS (HPUS*): Camphora 3X, 30C, Arsenicum Album 30C, Bryonia Alba 30C, Drosera Rotundifolia 30C, Ipecacuanha 30C, Kali Carbonicum 30C, Phosphorus 30C, Pulsatilla 30C, Spongia Tosta 30C, Squilla Maritima 30C.

Section 34093-5

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

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

Section 50565-1

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

Section 51727-6

INACTIVE INGREDIENTS: Acacia Gum, Anise Oil, Citric Acid, Eucalyptus Oil, Glycerin, Herbal Base [Chamomile (flower), Echinacea Angustifolia (Flower), Iceland Moss (Herb), Marshmallow (Root), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Herb)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor, Potassium Sorbate, Purified Water.

Section 51945-4

NDC: 43406-0664-4

COUGH SYRUP

HOMEOPATHIC

Natural Cherry / Mixed Berry Flavor

4 fl oz (120 mL)

Section 53413-1

QUESTIONS & COMMENTS?

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

Section 55105-1

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

Section 55106-9

ACTIVE INGREDIENTS (HPUS*): Camphora 3X, 30C, Arsenicum Album 30C, Bryonia Alba 30C, Drosera Rotundifolia 30C, Ipecacuanha 30C, Kali Carbonicum 30C, Phosphorus 30C, Pulsatilla 30C, Spongia Tosta 30C, Squilla Maritima 30C.


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

Dosage and Administration (34068-7)

DIRECTIONS: Adults & children above 4 years: 1 teaspoon (5mL) every 2-3 hours, or as directed by a health care professional. Shake well before use.

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 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)

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

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Acacia Gum, Anise Oil, Citric Acid, Eucalyptus Oil, Glycerin, Herbal Base [Chamomile (flower), Echinacea Angustifolia (Flower), Iceland Moss (Herb), Marshmallow (Root), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Herb)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor, Potassium Sorbate, Purified Water.

Section 51945-4 (51945-4)

NDC: 43406-0664-4

COUGH SYRUP

HOMEOPATHIC

Natural Cherry / Mixed Berry Flavor

4 fl oz (120 mL)

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

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

Section 55105-1 (55105-1)

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS*): Camphora 3X, 30C, Arsenicum Album 30C, Bryonia Alba 30C, Drosera Rotundifolia 30C, Ipecacuanha 30C, Kali Carbonicum 30C, Phosphorus 30C, Pulsatilla 30C, Spongia Tosta 30C, Squilla Maritima 30C.


Advanced Ingredient Data


Raw Label Data

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