Drugplain

Headache 12 [hp_X]/mL

Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis · LIQUID · BioActive Nutritionals, Inc.

10 Recalls on Record
Plain English

Headache is a liquid containing melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia (alba), cimicifuga racemosa, gelsemium sempervirens, glonoinum, magnesia phosphorica, nux vomica, sanguinaria canadensis, silicea, tarentula cubensis at 12 [hp_X]/mL, taken oral. Manufactured by BioActive Nutritionals, Inc..

Key Facts

Brand Name
Headache
Generic Name
Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis
NDC Code (Product)
43857-0488
Manufacturer
BioActive Nutritionals, Inc.
Strength
12 [hp_X]/mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Drug Class
Nitrate Vasodilator [EPC]; Non-Standardized Food Allergenic Extract [EPC]
Marketing Start
07/19/2018

Recall History

10 Recalls on Record
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II07/18/2012

LNK International, Inc.

Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II12/22/2015

Grato Holdings, Inc.

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

TerminatedVoluntary: Firm initiated
Class II06/06/2013

Novartis Consumer Health

Defective container: products are packaged in pouches which may not have been fully sealed

TerminatedVoluntary: Firm initiated
Class III05/15/2013

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

TerminatedVoluntary: Firm initiated
Class II12/06/2021

Medique Products

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class III08/03/2020

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective17,324 reports
fatigue8,589 reports
headache7,634 reports
nausea7,479 reports
pain7,439 reports
diarrhoea6,343 reports
dizziness6,195 reports
dyspnoea6,033 reports
off label use5,952 reports
arthralgia5,663 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves minor aches and pains due to: headache muscular aches

Dosage & Administration

Directions do not use more than directed adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours children under 12 years: ask a doctor

Warnings

Warnings Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if any new symptoms occur painful area is red o

Frequently Asked Questions

What is Headache used for?

Headache contains Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis. It is a liquid taken oral. Consult your doctor for specific uses.

Is Headache a controlled substance?

Headache is not classified as a controlled substance by the DEA.

What is the generic name for Headache?

The generic name for Headache is Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis. There are no other listed brand versions of Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis.

What is the NDC code for Headache 12 [hp_X]/mL?

The NDC (National Drug Code) for Headache 12 [hp_X]/mL is 43857-0488, listed by BioActive Nutritionals, Inc..

Product NDC

43857-0488

Package NDC

43857-0488-1

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

Data from openFDA · Public domain (CC0 1.0)