Drug Facts
Drug Facts
Baby Calming
FDA Label NDC 54973-3308
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 for the product Baby Calming (NDC 54973-3308). 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 drug facts, otc - purpose, uses, consult a physician if:, otc - keep out of reach of children, other, 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 Pharmacopœia of the United States. | |
| Chamomilla 6X HPUS | occasional sleeplessness, fussiness, and agitation |
| Coffea Cruda 6X HPUS | irritability |
| Ignatia Amara 30X HPUS
(less than 0.0000000000001% Alkaloids, calculated) | restless sleep |
| Lycopodium 30X HPUS | unpredictable, irregular sleep |
| Natrum Muriaticum 6X HPUS | crying, irritability |
| Platinum Metallicum 30X HPUS | causeless crying, waking at night |
| Pulsatilla 6X HPUS | cries easily, inconsolable |
| Sulphur 12X HPUS | crying, restlessness, irritability |
Uses
Temporarily relieves the symptoms of occasional sleeplessness, fussiness, agitation, irritability and restless sleep; unpredictable, irregular sleep; waking at night; crying; inconsolable behavior.
Consult A Physician If:
- symptoms persist for more than 72 hours or worsen
- symptoms are accompanied by a fever
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.
Other
Do not use if imprinted tamper-evident bottle cap band is broken or missing.
The inner packaged bottle is child-resistant. 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 a 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 under 1 year of age | dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved |
children 1 to under 3 years of age | dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved |
Inactive Ingredients
Acacia Gum, Lactose.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - 125 Tablet Bottle Carton
NDC 54973-3308-1
HOMEOPATHIC
Natural
Relief
Ages
6 months+
SINCE 1903
Hyland's®
Baby
Daytime
Calming
Tablets
RELIEF OF OCCASIONAL
SLEEPLESSNESS, FUSSINESS,
AND IRRITABILITY*
‣ No Artificial Flavors, Dyes or Parabens
ACTUAL SIZE 65 MG
125 QUICK-DISSOLVING TABLETS
* Please review the disclaimer below.
