Otc - Purpose
Headache Relief
Headache Relief Tablet
FDA Label NDC 54973-4008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Headache Relief (NDC 54973-4008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, active ingredients, uses, otc - pregnancy or breast feeding, otc - do not use, otc - ask doctor, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Active ingredients | Purpose |
Belladonna 12X HPUS (0.0000000000003% Alkaloids, calculated) | headache |
Gelsemium Sempervirens 6X HPUS | headache |
Ipecacuanha 6X HPUS | headache |
Iris Versicolor 6X HPUS | headache |
"HPUS" indicates that the active ingredients are in the official Homeopathic
Pharmacopoeia of the United States.
Uses
■ Temporarily relieves headaches
Otc - Pregnancy Or Breast Feeding
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Otc - Do Not Use
Do not use more than directed.
Otc - Ask Doctor
Consult a physician if:
■ symptoms persist for more than 7 days or worsen.
■ new symptoms occur.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
Overdosage
In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Directions
Adults and children 12 years and over | Dissolve 2 tablets under tongue every 15 minutes up to 4 doses, then every 4 hours until relieved. |
Children under 12 years | Consult a physician. |
Other Information
■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
Inactive Ingredients
Acacia Gum, Lactose.
Questions Or Comments?
(800) 624-9659
Other
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
Principal Display Panel
HOMEOPATHIC
NDC 54973-4008-1
SINCE 1903
Hyland's
Headache
Relief *
TOUGH ON PAIN - GENTLE ON YOU
NO ACETAMINOPHEN
NO IBUPROFEN
NO KNOWN DRUG
INTERACTIONS
100 QUICK-DISSOLVING
TABLETS
NATURAL
RELIEF
*SEE NOTE ON BACK PANEL BELOW DRUG FACTS
* Please review the disclaimer below.
