CALCAREA PHOSPHORICA 6X 6 [hp_X]/1

CALCAREA PHOSPHORICA · PELLET · SEVENE USA

2 Recalls on Record

Plain English

CALCAREA PHOSPHORICA 6X is a pellet containing calcarea phosphorica at 6 [hp_X]/1, taken sublingual. Manufactured by SEVENE USA.

Key Facts

Brand Name: CALCAREA PHOSPHORICA 6X
Generic Name: CALCAREA PHOSPHORICA
NDC Code (Product): 76472-4089
Manufacturer: SEVENE USA
Strength: 6 [hp_X]/1
Dosage Form: PELLET
Route: SUBLINGUAL
Marketing Status
Marketing Start: 06/26/2023

Recall History

2 Recalls on Record

Class II11/08/2019

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

TerminatedVoluntary: Firm initiated

Class I04/13/2017

Standard Homeopathic Company

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

asthenia3 reports

balance disorder3 reports

depression3 reports

diarrhoea3 reports

dyspnoea3 reports

gait disturbance3 reports

haemoglobin decreased3 reports

hallucination3 reports

heart rate increased3 reports

hemiparesis3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of minor muscle cramps menstrual cramps Directions Tip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under the tongue. Adults and Adolescents (12 years and older): Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

Dosage & Administration

Directions Tip bottle slightly allowing for tablets to fall into the cap. Use cap to drop tablets into mouth and allow them to dissolve under the tongue. Adults and Adolescents (12 years and older): Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

Warnings

Warnings Do not use if you ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if symptoms persist or worsen. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is CALCAREA PHOSPHORICA 6X used for?

CALCAREA PHOSPHORICA 6X contains CALCAREA PHOSPHORICA. It is a pellet taken sublingual. Consult your doctor for specific uses.

Is CALCAREA PHOSPHORICA 6X a controlled substance?

CALCAREA PHOSPHORICA 6X is not classified as a controlled substance by the DEA.

What is the generic name for CALCAREA PHOSPHORICA 6X?

The generic name for CALCAREA PHOSPHORICA 6X is CALCAREA PHOSPHORICA. There are 11 other brand versions of CALCAREA PHOSPHORICA.

What is the NDC code for CALCAREA PHOSPHORICA 6X 6 [hp_X]/1?

The NDC (National Drug Code) for CALCAREA PHOSPHORICA 6X 6 [hp_X]/1 is 76472-4089, listed by SEVENE USA.

Product NDC

76472-4089

Package NDC

76472-4089-1

Other Calcarea Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)