A-4 30 [hp_X]/mL
COCOA, COFFEE BEAN, and TEA LEAF · SOLUTION · DNA Labs, Inc.
A-4 is an over-the-counter sublingual solution containing extracts from cocoa, coffee beans, and tea leaves that may be used to help build tolerance to these common food allergens. This non-standardized allergenic extract is placed under the tongue and is intended for patients with allergies to these substances.
Key Facts
- Brand Name
- A-4
- Generic Name
- COCOA, COFFEE BEAN, and TEA LEAF
- NDC Code (Product)
58264-0296- Manufacturer
- DNA Labs, Inc.
- Strength
- 30 [hp_X]/mL
- Dosage Form
- SOLUTION
- Route
- SUBLINGUAL
- Marketing Status
- Drug Class
- Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]
- Marketing Start
- 01/01/1990
Recall History
Little Moon Essentials LLC
CGMP deviations
BioLyte Laboratories, LLC
CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
Qualitest Pharmaceuticals
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
TCP HRB ACQUISITON LLC
Chemical contamination: Presence of benzene
Shadow Holdings DBA Bocchi Labs
CGMP Deviations: products may be contaminated with bacteria.
Denton Pharma, Inc.
CGMP Deviations: Presence of NDMA impurity detected in product.
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Unilever United States Inc.
Chemical contamination: presence of benzene
Full Prescribing Information
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-4 used for?
A-4 is an over-the-counter sublingual solution containing extracts from cocoa, coffee beans, and tea leaves that may be used to help build tolerance to these common food allergens. This non-standardized allergenic extract is placed under the tongue and is intended for patients with allergies to these substances.
Is A-4 a controlled substance?
A-4 is not classified as a controlled substance by the DEA.
What is the generic name for A-4?
The generic name for A-4 is COCOA, COFFEE BEAN, and TEA LEAF. There are no other listed brand versions of COCOA, COFFEE BEAN, and TEA LEAF.
What is the NDC code for A-4 30 [hp_X]/mL?
The NDC (National Drug Code) for A-4 30 [hp_X]/mL is 58264-0296, listed by DNA Labs, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)