Other
Drug Facts
Cold Tablet
FDA Label NDC 54973-3010
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 Cold (NDC 54973-3010). 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 other, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
sneezing, headache
red, runny eyes, nose
runny nose, eyes & sore throat
runny nose & sore throat
Indications & Usage
Uses
Temporarily relieves the symptoms of the common cold.
Warnings
Warnings
Stop use and ask a doctor if:
- symptoms persist for more than 7 days or worsen
- inflammation, fever or infection develops
- symptoms are acccompanied by a high fever (101°F)
If pregnant or breast-feeding, ask a health professional before use.
Do not use if imprinted tamper band is broken or missing.
In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days a week at 800-624-9659.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.
Dosage & Administration
Directions
Adults and children 12 years and over:
dissolve 2-3 tablets under tongue every 4 hours or as needed.
Children 6-12 years:
half adult dose.
Inactive Ingredient
Acacia Gum, Lactose N.F.
Otc - Questions
Questions or Comments?
800- 624-9659
Otc - Active Ingredient
Active Ingredients
Aconitum Napellus 6X HPUS
Allium Cepa 6X HPUS
Zincum Gluconicum 2X HPUS
Gelsemium Semp. 6X HPUS
HPUS indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States
Package Label.Principal Display Panel
Principal Display Panel - 50 Tablet Bottle Carton
Natural
Relief
NDC 54973-3010-1
HOMEOPATHIC*
SINCE 1903
Hyland's
Cold
Tablets
with Zinc
Multi-Symptom
Non-Drowsy Formula
RELIEVES
Sore Throat
Nasal Congestion
Runny Nose, Sneezing
hylands.com
Hyland's
Homeopathic
Safe & Effective
Cold
Tablets
with Zinc
50
Quick-Dissolving Tablets
All Natural
Safe & Effective
Hyland's
*The uses for our products are based
upon traditional homeopathic practice.
They have not been reviewed by the
Food and Drug Administration.
All Natural
Safe & Effective
PLEASE RECYCLE
3 54973 30101 6
COLD TABLETS
WITH ZINC
* Please review the disclaimer below.
