NauseaCalm

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:27:41

Label at a glance#

ProductNauseaCalm
Active ingredientTOBACCO LEAF, KEROSENE, IPECAC, STRYCHNOS NUX-VOMICA SEED, ANAMIRTA COCCULUS SEED
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

Purpose*

Relieves Nausea, Vomiting, Upset Stomach, Indigestion, Dizziness

INDICATIONS & USAGE SECTION

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

OTC - ASK DOCTOR SECTION

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

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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.

INACTIVE INGREDIENT SECTION

lactose. sucrose

OTC - QUESTIONS SECTION

1-800-264-7661

Made in France

Distributed by Boiron, Inc. Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

  • 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9245-41NauseaCalm80 in 1 TUBEPELLET801
0220-9245-42NauseaCalm2 in 1 BOXPELLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9245NAUSEACALM (ANAMIRTA COCCULUS SEED, IPECAC, STRYCHNOS NUX-VOMICA SEED, TOBACCO LEAF, KEROSENE) PELLET [BOIRON]1Current NDC, 2 package rows20240802_1e8e0388-c5c8-d4da-e063-6394a90ab294.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-92450220-9245-41, 0220-9245-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NauseaCalmANAMIRTA COCCULUS SEED, IPECAC, STRYCHNOS NUX-VOMICA SEED, TOBACCO LEAF, KEROSENEBoiron1e8e0388-c5c8-d4da-e063-6394a90ab2942024-07-31Exact identifier
ndc (package): 0220-9245-42
ndc (package): 0220-9245-41
ndc (product): 0220-9245
ndc11 (package): 00220924541
ndc11 (package): 00220924542
spl id: 1e8e0388-c5c9-d4da-e063-6394a90ab294
spl set id: 1e8e0388-c5c8-d4da-e063-6394a90ab294

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.