Otc - Active Ingredient
Active Ingredients:
Chamomilla (chamomile) 3X HPUS
Coffea cruda (coffee seed) 3X HPUS
Calcarea phosphorica (calcium phosphate) 12X HPUS
Humphreys Baby Teething Relief Cherry Swift Strips
FDA Label NDC 0219-4103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humphreys Pharmacal, Incorporated for the product Humphreys Baby Teething Relief Cherry Swift Strips (NDC 0219-4103). 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 - active ingredient, purpose, uses:, warnings:, otc - stop use, otc - keep out of reach of children, directions:, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Chamomilla (chamomile) 3X HPUS....................pain & irritability reliever
Coffea cruda (coffee seed) 3X HPUS..................calming aid
Calcarea phosphorica (calcium phosphate) 12X....supports dentition
Uses:
Temporarily relieves minor irritation, pain and wakefulness associated with teething in infants.
Warnings:
Do not use if packet seal is torn or broken.
Otc - Stop Use
Stop use and ask doctor if
- symptoms persist for more than 7 days or if irritation persists
- inflammation, fever or infection develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions:
Open packet, tear in half along perforation. Peel from corner to
expose strip. Place 1 strip on tongue and allow to dissolve. If
needed, repeat every 2 hours up to 4 times per day. If child is
persistently irritable, wakeful and restless, administer 1 strip
before bed - repeat if necessary or as directed by a healthcare professional.
Inactive Ingredients
beet juice extract, carrageenan, glycerin, gum arabic, maltodextrin,
natural flavor, oat fiber, pectin, polysorbate 80, stevia, vanillin, xylitol
Otc - Questions
Questions or Comments?
1-866-267-8710 or
www.humphreysbaby.com
Distributed by: Humphreys Pharmacal, Inc.
East Hampton, CT 06424
Made in USA
Package Label.Principal Display Panel
Cherry Strip Carton Fc79 (Fc79)
* Please review the disclaimer below.
