Nauseacalm Pellets

Nauseacalm Pellets
SPL v1
SPL
SPL Set ID 1e8e0388-c5c8-d4da-e063-6394a90ab294
Route
ORAL
Published
Effective Date 2024-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tobacco Leaf (4 [hp_C]) Kerosene Ipecac Strychnos Nux-vomica Seed Anamirta Cocculus Seed
Inactive Ingredients
Sucrose Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-07-31

Description

Active ingredients ** Cocculus indicus 4C HPUS (0.09 mg) (contains less than 10 -10 mg picrotoxinin) Ipecacuanha 4C HPUS (0.09 mg) (contains less than 10 -10 mg emetine alkaloids) Nux Vomica 4C HPUS (0.09 mg) (contains less than 10 -10 mg strychnine alkaloids) Petroleum 4C HPUS (0.09 mg) (contains less than 10 -11 mg aromatic hydrocarbons) Tabacum 4C HPUS (0.09 mg) (contains less than 10- 10 mg nicotine alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Indications and Usage

Uses*

  • for relief of nausea and vomiting associated with:
  • upset stomach
  • overindulgence in food or drink
  • stomach flu

  • for relief of nausea, vomiting, or dizziness associated with motion sickness
Dosage and Administration
  • Adults and children 2 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue. Repeat if necessary until symptoms improve, up to 3 times per day.
  • Children under 2 years of age: Ask a doctor.
Description

Active ingredients ** Cocculus indicus 4C HPUS (0.09 mg) (contains less than 10 -10 mg picrotoxinin) Ipecacuanha 4C HPUS (0.09 mg) (contains less than 10 -10 mg emetine alkaloids) Nux Vomica 4C HPUS (0.09 mg) (contains less than 10 -10 mg strychnine alkaloids) Petroleum 4C HPUS (0.09 mg) (contains less than 10 -11 mg aromatic hydrocarbons) Tabacum 4C HPUS (0.09 mg) (contains less than 10- 10 mg nicotine alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5
  • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
  • contains 0.25 g of sugar per dose

MULTI-SYMPTOM NAUSEA RELIEF*

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1

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

Section 50566-9

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

Section 50569-3

Ask a doctor before use if nausea or vomiting is accompanied by

  • diarrhea
  • severe headache
  • fever
  • severe abdominal pain or cramping
Section 51727-6

lactose. sucrose

Section 51945-4

Section 53413-1

1-800-264-7661

Made in France

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose*

Relieves Nausea, Vomiting, Upset Stomach, Indigestion, Dizziness

Section 55106-9

Active ingredients **

Cocculus indicus 4C HPUS (0.09 mg) (contains less than 10 -10 mg picrotoxinin)

Ipecacuanha 4C HPUS (0.09 mg) (contains less than 10 -10 mg emetine alkaloids)

Nux Vomica 4C HPUS (0.09 mg) (contains less than 10 -10 mg strychnine alkaloids)

Petroleum 4C HPUS (0.09 mg) (contains less than 10 -11 mg aromatic hydrocarbons)

Tabacum 4C HPUS (0.09 mg) (contains less than 10- 10 mg nicotine alkaloids)

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


Structured Label Content

Indications and Usage (34067-9)

Uses*

  • for relief of nausea and vomiting associated with:
  • upset stomach
  • overindulgence in food or drink
  • stomach flu

  • for relief of nausea, vomiting, or dizziness associated with motion sickness
Dosage and Administration (34068-7)
  • Adults and children 2 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue. Repeat if necessary until symptoms improve, up to 3 times per day.
  • Children under 2 years of age: Ask a doctor.
Section 42229-5 (42229-5)
  • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
  • contains 0.25 g of sugar per dose

MULTI-SYMPTOM NAUSEA RELIEF*

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

Ask a doctor before use if nausea or vomiting is accompanied by

  • diarrhea
  • severe headache
  • fever
  • severe abdominal pain or cramping
Section 51727-6 (51727-6)

lactose. sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-264-7661

Made in France

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

Relieves Nausea, Vomiting, Upset Stomach, Indigestion, Dizziness

Section 55106-9 (55106-9)

Active ingredients **

Cocculus indicus 4C HPUS (0.09 mg) (contains less than 10 -10 mg picrotoxinin)

Ipecacuanha 4C HPUS (0.09 mg) (contains less than 10 -10 mg emetine alkaloids)

Nux Vomica 4C HPUS (0.09 mg) (contains less than 10 -10 mg strychnine alkaloids)

Petroleum 4C HPUS (0.09 mg) (contains less than 10 -11 mg aromatic hydrocarbons)

Tabacum 4C HPUS (0.09 mg) (contains less than 10- 10 mg nicotine alkaloids)

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


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