Nauseacalm Tablets

Nauseacalm Tablets
SPL v4
SPL
SPL Set ID c846971d-fcf8-2cf4-e053-2995a90aaec8
Route
ORAL
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: Boiron Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-07-29

Description

Active ingredient** (in each tablet) Cocculus indicus 4C HPUS (0.5 mg) (contains less than 10 -10 mg picrotoxinin) Ipecacuanha 4C HPUS (0.5 mg) (contains less than 10 -10 mg emetine alkaloids) Nux Vomica 4C HPUS (0.5 mg) (contains less than 10 -10 strychnine alkaloids) Petroleum 4C HPUS (0.5 mg) (contains less than 10 -10 aromatic hydrocarbons) Tabacum 4C HPUS (0.5 mg) (contains less than 10 -10 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
  • fullness due to overindulgence in food and drink
  • stomach flu
  • for relief of nausea, vomiting, or dizziness associated with motion from travel, amusement rides, or video games
Dosage and Administration

Directions

Adults and children 7 years of age and older - At the onset of symptoms, dissolve 2 tablets in the mouth. Repeat if necessary until symptoms improve, up to 3 times per day.

Children 2 to 6 years of age - Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

Children under 2 years of age - Ask a doctor.

Description

Active ingredient** (in each tablet) Cocculus indicus 4C HPUS (0.5 mg) (contains less than 10 -10 mg picrotoxinin) Ipecacuanha 4C HPUS (0.5 mg) (contains less than 10 -10 mg emetine alkaloids) Nux Vomica 4C HPUS (0.5 mg) (contains less than 10 -10 strychnine alkaloids) Petroleum 4C HPUS (0.5 mg) (contains less than 10 -10 aromatic hydrocarbons) Tabacum 4C HPUS (0.5 mg) (contains less than 10 -10 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 the blister seal is broken

store below 86° F (30° C)

Nausea Relief*

No Aspirin or Caffeine

60 Meltaway Tablets unflavored

100 Meltaway Tablets unflavored

No Known Drug Interactions

*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 overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Ask a doctor before useif nausea or vomiting is accompanied by

  • diarrhea
  • severe headache
  • fever
  • severe abdominal pain or cramping.

Section 51727-6

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

Questions or Comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Made if 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*

Cocculus indicus 4C HPUS ... Relieves nausea or vomiting with dizziness and the need to lie down

Ipecacuanha 4C HPUS ... Relieves nausea and vomiting with hypersalivation

Nux Vomica 4C HPUS ... Relieves upset stomach, indigestion, nausea, and vomiting

Petroleum 4C HPUS ... Relieves nausea improved by eating

Tabacum 4C HPUS ... Relieves dizziness, nausea and vomiting improved by fresh air

Section 55106-9

Active ingredient** (in each tablet)

Cocculus indicus 4C HPUS (0.5 mg) (contains less than 10 -10 mg picrotoxinin)

Ipecacuanha 4C HPUS (0.5 mg) (contains less than 10 -10 mg emetine alkaloids)

Nux Vomica 4C HPUS (0.5 mg) (contains less than 10 -10 strychnine alkaloids)

Petroleum 4C HPUS (0.5 mg) (contains less than 10 -10 aromatic hydrocarbons)

Tabacum 4C HPUS (0.5 mg) (contains less than 10 -10 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
  • fullness due to overindulgence in food and drink
  • stomach flu
  • for relief of nausea, vomiting, or dizziness associated with motion from travel, amusement rides, or video games
Dosage and Administration (34068-7)

Directions

Adults and children 7 years of age and older - At the onset of symptoms, dissolve 2 tablets in the mouth. Repeat if necessary until symptoms improve, up to 3 times per day.

Children 2 to 6 years of age - Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

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 the blister seal is broken

store below 86° F (30° C)

Nausea Relief*

No Aspirin or Caffeine

60 Meltaway Tablets unflavored

100 Meltaway Tablets unflavored

No Known Drug Interactions

*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 overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Ask a doctor before useif nausea or vomiting is accompanied by

  • diarrhea
  • severe headache
  • fever
  • severe abdominal pain or cramping.

Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Made if 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*

Cocculus indicus 4C HPUS ... Relieves nausea or vomiting with dizziness and the need to lie down

Ipecacuanha 4C HPUS ... Relieves nausea and vomiting with hypersalivation

Nux Vomica 4C HPUS ... Relieves upset stomach, indigestion, nausea, and vomiting

Petroleum 4C HPUS ... Relieves nausea improved by eating

Tabacum 4C HPUS ... Relieves dizziness, nausea and vomiting improved by fresh air

Section 55106-9 (55106-9)

Active ingredient** (in each tablet)

Cocculus indicus 4C HPUS (0.5 mg) (contains less than 10 -10 mg picrotoxinin)

Ipecacuanha 4C HPUS (0.5 mg) (contains less than 10 -10 mg emetine alkaloids)

Nux Vomica 4C HPUS (0.5 mg) (contains less than 10 -10 strychnine alkaloids)

Petroleum 4C HPUS (0.5 mg) (contains less than 10 -10 aromatic hydrocarbons)

Tabacum 4C HPUS (0.5 mg) (contains less than 10 -10 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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Raw Label Data

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