FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Stop use and ask a doctor if:
- symptoms persist for more than 72 hours or worsen
- symptoms are accompanied by a fever
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Stop use and ask a doctor if:
- symptoms persist for more than 72 hours or worsen
- symptoms are accompanied by a fever
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Temporarily relieves the symptoms of occasional sleeplessness, fussiness, agitation, irritability and restless sleep; unpredictable, irregular sleep; waking at night; crying; inconsolable behavior.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Calming Manufacturers
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Hyland’s
Calming | Hyland's
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
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