Other
DAYTIME
Drug Facts
NIGHTTIME
Drug Facts
Tiny Cold Tablet, Soluble
FDA Label NDC 54973-3158
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 Tiny Cold (NDC 54973-3158). 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, uses, otc - ask doctor, otc - keep out of reach of children, otc - do not use, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopæia of the United States. | |
| Eupatorium Perfoliatum 6X HPUS | headache, cough, sneezing |
| Euphrasia Officinalis 6X HPUS | runny eyes & nose |
| Gelsemium Sempervirens 6X HPUS | sneezing with stuffy nose |
| Kali Iodatum 6X HPUS | headache, runny eyes & nose |
| Active ingredients | Purpose |
|---|---|
| "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopæia of the United States. | |
| Chamomilla 6X HPUS | occasional sleeplessness |
| Eupatorium Perfoliatum 6X HPUS | headache, cough, sneezing |
| Euphrasia Officinalis 6X HPUS | runny eyes, nose and nighttime coughing |
| Gelsemium Sempervirens 6X HPUS | sneezing with stuffy nose and occasional sleeplessness |
| Kali Iodatum 6X HPUS | headache, runny eyes & nose and occasional sleeplessness |
Uses
Temporarily relieves the symptoms of runny nose, congestion and sneezing due to common head colds in children.
Temporarily relieves the symptoms of runny nose and eyes, nighttime cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.
Otc - Ask Doctor
Consult a physician if:
- symptoms persist for more than 72 hours or worsen
- symptoms are accompanied by a high fever (over 101°F)
- symptoms persist for more than 72 hours or worsen
- symptoms are accompanied by a high fever (over 101°F)
Consult a physician if:
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.
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.
Otc - Do Not 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 also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
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 also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Directions
Children under 6 months of age: consult a licensed health care professional before using this product.
Children 6 months to 1 year of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.
Children 1 to 3 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.
Hyland's Baby Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.
Children under 6 months of age: consult a licensed health care professional before using this product.
Children 6 months to 1 year of age: dissolve 2 tablets on tongue every 4 hours during the night as required.
Children 1 to 3 years of age: dissolve 3 tablets on tongue every 4 hours during the night as required.
Hyland's Baby Nighttime Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.
Inactive Ingredients
Acacia Gum, Lactose.
Acacia Gum, Lactose.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - Kit Carton
Day
& Night
Value Pack
SINCE 1903
Hyland's®
Baby
NDC 54973-3307-1
HOMEOPATHIC
Ages 6 months+
Natural
Relief
Daytime
Tiny Cold
Tablets
RELIEF OF RUNNY NOSE,
CONGESTION AND
SNEEZING DUE TO COLDS*
Nighttime
Tiny Cold
Tablets
RELIEF OF RUNNY NOSE,
CONGESTION, AND
OCCASIONAL SLEEPLESSNESS
DUE TO COLDS*
‣ No Artificial Flavors, Dyes or Parabens
2 Bottles of 125 Quick-Dissolving Tablets / 250 Tablets Total
* Please review the disclaimer below.
