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 Original
FDA Label NDC 0219-6103
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 Original (NDC 0219-6103). 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....................irritation reliever
Coffea cruda (coffee seed) 3X HPUS..................calming aid
Calcarea phosphorica (calcium phosphate) 12X....supports dentition
Uses
Temporarily relieves minor pain, irritability and wakefulness associated with teething in infants.
Warnings
Do not use if cap seal is broken or missing.
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
Place 1 to 3 pellets in 1/2 teaspoon of water and allow to dissolve.
After dissolving, apply immediately to child's gums. If needed, repeat every 2 hours
up to 4 times per day. If preferred, mixture may be administered under the tongue.
If child is persistently irritable wakeful and restless, administer 3 pellets before bed
- repeat if necessary or as directed by a healthcare professional.
Inactive Ingredients
corn starch NF, sucrose NF (sugar)
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
Original Teething Pellet Carton Fc77 (Fc77)
* Please review the disclaimer below.
