Drugplain

Headache Relief 8 [hp_C]/4g

atropa belladonna, cyclamen purpurascens tuber, coffea arabica seed, roasted, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark · PELLET · Homeocare Laboratories

2 Recalls on Record
Plain English

Headache Relief is a pellet containing atropa belladonna, cyclamen purpurascens tuber, coffea arabica seed, roasted, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark at 8 [hp_C]/4g, taken sublingual. Manufactured by Homeocare Laboratories.

Key Facts

Brand Name
Headache Relief
Generic Name
atropa belladonna, cyclamen purpurascens tuber, coffea arabica seed, roasted, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark
NDC Code (Product)
61727-305
Manufacturer
Homeocare Laboratories
Strength
8 [hp_C]/4g
Dosage Form
PELLET
Route
SUBLINGUAL
Marketing Status
Drug Class
Non-Standardized Plant Allergenic Extract [EPC]
Marketing Start
07/20/2012

Recall History

2 Recalls on Record
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

pain86 reports
off label use79 reports
drug ineffective76 reports
dyspnoea64 reports
drug interaction63 reports
sinusitis59 reports
headache58 reports
pruritus56 reports
lower respiratory tract infection54 reports
mobility decreased50 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache arthritis a cold muscular aches toothache premenstrual and menstrual cramps

Dosage & Administration

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours. children under 12 years: ask a doctor

Warnings

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: shock facial swelling hives asthma (wheezing) 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 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using t

Frequently Asked Questions

What is Headache Relief used for?

Headache Relief contains atropa belladonna, cyclamen purpurascens tuber, coffea arabica seed, roasted, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark. It is a pellet taken sublingual. Consult your doctor for specific uses.

Is Headache Relief a controlled substance?

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

What is the generic name for Headache Relief?

The generic name for Headache Relief is atropa belladonna, cyclamen purpurascens tuber, coffea arabica seed, roasted, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark. There are no other listed brand versions of atropa belladonna, cyclamen purpurascens tuber, coffea arabica seed, roasted, iris versicolor root, strychnos nux-vomica seed, sanguinaria canadensis root, spigelia marilandica root, viburnum opulus bark.

What is the NDC code for Headache Relief 8 [hp_C]/4g?

The NDC (National Drug Code) for Headache Relief 8 [hp_C]/4g is 61727-305, listed by Homeocare Laboratories.

Product NDC

61727-305

Package NDC

61727-305-21

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

Data from openFDA · Public domain (CC0 1.0)