FDA Label for Nauseacalm
View Indications, Usage & Precautions
Nauseacalm Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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)
Tabacum 4C HPUS (0.5 mg) (contains less than 10 -10 nicotine alkaloids)
Petroleum 4C HPUS (0.5 mg) (contains less than 10 -10 aromatic hydrocarbons)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
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
Indications & 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
Otc - Stop Use
Stop use and ask a doctor if nausea or vomiting is accompanied by
diarrhea
severe headache
fever
severe abdominal pain or cramping
Stop use and ask a doctor if symptoms persist for more than 2 days or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & 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.
Inactive Ingredient
croscarmellose sodium, lactose, magnesium stearate
Other
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*
Upset Stomach Stomach Flu*
Relieves Upset Stomach*
Relieves Nausea & Vomiting*
No Aspirin or Caffeine
60 Meltaway Tablets unflavored
Meltaway Tablets Require No Food or Water
No Artificial Colors, Flavors, Sweeteners, or Preservatives
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.
Otc - Questions
Questions or Comments?
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Made if France
Distributed by Boiron Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
