Drugplain

Body Balance 4 [hp_X]/41mL

Aralia quin, Arnica, Avena, Carduus mar, Elaeis, Glandula suprarenalis suis, Nat mur, Phosphoricum ac, Thuja occ · LIQUID · Eight and Company L.L.C

2 Recalls on Record
Plain English

Body Balance is a liquid containing aralia quin, arnica, avena, carduus mar, elaeis, glandula suprarenalis suis, nat mur, phosphoricum ac, thuja occ at 4 [hp_X]/41mL, taken oral. Manufactured by Eight and Company L.L.C.

Key Facts

Brand Name
Body Balance
Generic Name
Aralia quin, Arnica, Avena, Carduus mar, Elaeis, Glandula suprarenalis suis, Nat mur, Phosphoricum ac, Thuja occ
NDC Code (Product)
61096-1039
Manufacturer
Eight and Company L.L.C
Strength
4 [hp_X]/41mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Marketing Start
02/28/2019

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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.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 Aralia quin, Arnica, Avena, Carduus mar, Elaeis, Glandula suprarenalis suis, Nat mur, Phosphoricum ac, Thuja occ. It is a liquid 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 Aralia quin, Arnica, Avena, Carduus mar, Elaeis, Glandula suprarenalis suis, Nat mur, Phosphoricum ac, Thuja occ. There are no other listed brand versions of Aralia quin, Arnica, Avena, Carduus mar, Elaeis, Glandula suprarenalis suis, Nat mur, Phosphoricum ac, Thuja occ.

What is the NDC code for Body Balance 4 [hp_X]/41mL?

The NDC (National Drug Code) for Body Balance 4 [hp_X]/41mL is 61096-1039, listed by Eight and Company L.L.C.

Product NDC

61096-1039

Package NDC

61096-1039-1

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

Data from openFDA · Public domain (CC0 1.0)