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  5. Label Information: Humphreys Baby Teething Relief Original

FDA Label for Humphreys Baby Teething Relief Original

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. INACTIVE INGREDIENTS
    9. OTC - QUESTIONS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Humphreys Baby Teething Relief Original Product Label

The following document was submitted to the FDA by the labeler of this product Humphreys Pharmacal, Incorporated. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients

Chamomilla (chamomile) 3X HPUS

Coffea cruda (coffee seed) 3X HPUS

Calcarea phosphorica (calcium phosphate) 12X HPUS


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

Original Teething Pellet Carton FC77 - FC77



* Please review the disclaimer below.