Otc - Purpose
Temporarily reduces fevers and relieves pain
Fever Reducer Tablet
FDA Label NDC 54973-4010
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 Fever Reducer (NDC 54973-4010). 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 - stop use, otc - keep out of reach of children, other, 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 |
Aconitum Napellus 6X HPUS | fever reducer/pain reliever |
Belladonna 6X HPUS (0.0000003% Alkaloids, calculated) | fever reducer/pain reliever |
Bryonia Alba 6X HPUS | fever reducer/pain reliever |
Gelsemium Sempervirens 6X HPUS | fever reducer/pain reliever |
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses
■ Temporarily reduces fevers and relieves pain
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 - Stop Use
Stop use and consult a physician if:
■ pain gets worse or lasts more than 7 days.
■ fever gets worse, is consistently 103°F (39.4°C) or higher or lasts more than 3 days.
■ new symptoms occur.
■ redness or swelling is present.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
Other
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.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,
NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
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
Principal Display Panel
HOMEOPATHIC
NDC 54973-4010-1
SINCE 1903
Hyland's
Fever
Reducer*
TOUGH ON PAIN - GENTLE ON YOU
NO ACETAMINOPHEN
NO IBURPTOFEN
NO KNOWN DRUG
INTERACTIONS
* Please review the disclaimer below.
