Drugplain

Body Balance 3 [hp_X]/mL

Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (Suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis · SPRAY · Energique, Inc.

2 Recalls on Record
Plain English

Body Balance is a spray containing avena sativa, chlorophytum borivilianum, nuphar luteum, hypothalamus suis, orchitinum (suis), damiana, selenium metallicum, staphysagria, thuja occidentalis at 3 [hp_X]/mL, taken oral. Manufactured by Energique, Inc..

Key Facts

Brand Name
Body Balance
Generic Name
Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (Suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis
NDC Code (Product)
44911-0635
Manufacturer
Energique, Inc.
Strength
3 [hp_X]/mL
Dosage Form
SPRAY
Route
ORAL
Marketing Status
Marketing Start
03/16/2021

Recall History

2 Recalls on Record
Class I08/02/2021

Je Dois Lavoir LLC

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

TerminatedVoluntary: Firm initiated
Class II10/09/2018

Sprayology

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

headache1 reports
influenza1 reports
kidney infection1 reports
premature labour1 reports
pyrexia1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS: Our adrenal glands can become exhausted from chronic stress, worry, overwork or poor nutrition. Temporarily relieves signs of adrenal exhaustion, including: ° dizziness fatigue & weakness ° mental stress ° loss of our sense of well being ° natural ° gluten & lactose free ° no artificial flavors or colors ° no known negative side effects ° no known negative drug interactions

Dosage & Administration

DIRECTIONS: For adults only. 2 sprays into the mouth 3 times per day.

Warnings

WARNINGS: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Body Balance used for?

Body Balance contains Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (Suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis. It is a spray taken oral. Consult your doctor for specific uses.

Is Body Balance a controlled substance?

Body Balance is not classified as a controlled substance by the DEA.

What is the generic name for Body Balance?

The generic name for Body Balance is Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (Suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis. There are no other listed brand versions of Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (Suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis.

What is the NDC code for Body Balance 3 [hp_X]/mL?

The NDC (National Drug Code) for Body Balance 3 [hp_X]/mL is 44911-0635, listed by Energique, Inc..

Product NDC

44911-0635

Package NDC

44911-0635-1

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

Data from openFDA · Public domain (CC0 1.0)