Label: NAUSEACALM- anamirta cocculus seed, ipecac, strychnos nux-vomica seed, tobacco leaf, kerosene tablet
- NDC Code(s): 0220-9244-04
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated May 31, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
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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
- WARNINGS
- STOP USE
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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
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SPL UNCLASSIFIED SECTION
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
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. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAUSEACALM
anamirta cocculus seed, ipecac, strychnos nux-vomica seed, tobacco leaf, kerosene tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9244 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 4 [hp_C] KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE 4 [hp_C] TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF 4 [hp_C] IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 4 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 4 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Boiron Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9244-04 1 in 1 CARTON 07/29/2021 1 60 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/29/2021 Labeler - Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9244)
