Drugplain

A-6 30 [hp_X]/mL

Lemon, Orange, and Grapefruit · SOLUTION · DNA Labs, Inc.

10 Recalls on Record
Plain English

A-6 is an over-the-counter sublingual solution containing a non-standardized food allergenic extract made from lemon, orange, and grapefruit that may be used for allergic reactions to these citrus fruits. This product is placed under the tongue for absorption and is intended to help manage symptoms related to citrus fruit allergies.

Key Facts

Brand Name
A-6
Generic Name
Lemon, Orange, and Grapefruit
NDC Code (Product)
58264-0298
Manufacturer
DNA Labs, Inc.
Strength
30 [hp_X]/mL
Dosage Form
SOLUTION
Route
SUBLINGUAL
Marketing Status
Drug Class
Non-Standardized Food Allergenic Extract [EPC]
Marketing Start
01/01/1990

Recall History

10 Recalls on Record
Class II09/12/2019

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class III11/17/2020

Fresenius Kabi USA, LLC

Cross Contamination with Other Products: trace amounts of octreotide found during testing

TerminatedVoluntary: Firm initiated
Class II03/16/2023

Northwind Pharmaceuticals LLC

CGMP Deviations

OngoingVoluntary: Firm initiated
Class II09/12/2019

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II10/23/2018

Janssen Pharmaceuticals, Inc.

Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS Allergies.

Dosage & Administration

SUGGESTED DOSAGE Normal dose for the first week is 2-3 drops in water T.I.D. Add one drop per dose per week until a total of ten drops is reached.

Warnings

Warnings Use only if cap seal is unbroken. If pregnant or breastfeeding, ask a healthcare professional before use. Keep this and all medication out of the reach of children.

Frequently Asked Questions

What is A-6 used for?

A-6 is an over-the-counter sublingual solution containing a non-standardized food allergenic extract made from lemon, orange, and grapefruit that may be used for allergic reactions to these citrus fruits. This product is placed under the tongue for absorption and is intended to help manage symptoms related to citrus fruit allergies.

Is A-6 a controlled substance?

A-6 is not classified as a controlled substance by the DEA.

What is the generic name for A-6?

The generic name for A-6 is Lemon, Orange, and Grapefruit. There are no other listed brand versions of Lemon, Orange, and Grapefruit.

What is the NDC code for A-6 30 [hp_X]/mL?

The NDC (National Drug Code) for A-6 30 [hp_X]/mL is 58264-0298, listed by DNA Labs, Inc..

Product NDC

58264-0298

Package NDC

58264-0298-1

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

Data from openFDA · Public domain (CC0 1.0)