Motioncalm

Motioncalm
SPL v2
SPL
SPL Set ID c77c3c90-0168-f7aa-e053-2995a90a9171
Route
ORAL
Published
Effective Date 2023-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: Boiron Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-07-23

Description

Active ingredients** (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 mg strychnine alkaloids) Tabacum 4C HPUS (0.5 mg) (contains less than 10-10 mg nicotine alkaloids) Petroleum 4C HPUS (0.5 mg) (contains less than 10-10 mg aromatic hydrocarbons) 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 the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness due to: travel, amusement rides, video games

Dosage and Administration

Directions

Adults and children 7 years of age and older

  • To prevent motion sickness, dissolve 2 tablets in the mouth on the evening before travel and day of travel.
  • To treat motion sickness, dissolve 2 tablets in the mouth at the onset of symptoms, then 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 ingredients** (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 mg strychnine alkaloids) Tabacum 4C HPUS (0.5 mg) (contains less than 10-10 mg nicotine alkaloids) Petroleum 4C HPUS (0.5 mg) (contains less than 10-10 mg aromatic hydrocarbons) 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)

60 meltaway tablets unflavored

Motion Sickness*

Nausea Vomiting Dizziness*

Prevents & Relieves Symptoms

Non-Drowsy

*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

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

Section 51727-6

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9

If pregnant or breastfeeding, 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

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

Petroleum 4C HPUS Relieves nausea improved by eating

Section 55106-9

Active ingredients** (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 mg strychnine alkaloids)

Tabacum 4C HPUS (0.5 mg) (contains less than 10-10 mg nicotine alkaloids)

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

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 the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness due to: travel, amusement rides, video games

Dosage and Administration (34068-7)

Directions

Adults and children 7 years of age and older

  • To prevent motion sickness, dissolve 2 tablets in the mouth on the evening before travel and day of travel.
  • To treat motion sickness, dissolve 2 tablets in the mouth at the onset of symptoms, then 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)

60 meltaway tablets unflavored

Motion Sickness*

Nausea Vomiting Dizziness*

Prevents & Relieves Symptoms

Non-Drowsy

*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)

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

Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

If pregnant or breastfeeding, 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

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

Petroleum 4C HPUS Relieves nausea improved by eating

Section 55106-9 (55106-9)

Active ingredients** (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 mg strychnine alkaloids)

Tabacum 4C HPUS (0.5 mg) (contains less than 10-10 mg nicotine alkaloids)

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

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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