Comfort For Teething

Comfort For Teething
SPL v8
SPL
SPL Set ID 21b44c37-4fc8-14b4-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2015-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Phosphate, Monobasic, Unspecified (6 [hp_X]) Chamomile (3 [hp_X]) Arnica Montana Calcium Cation Wood Creosote Rheum Officinale Root
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-07-05

Description

Do not use if printed neck seal is broken or missing use only as directed. For infants 4 months and older: give 4 drops under the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours or as recommended by a doctor.


Medication Information

Indications and Usage

For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething

Description

Do not use if printed neck seal is broken or missing use only as directed. For infants 4 months and older: give 4 drops under the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours or as recommended by a doctor.

Section 50565-1

Keep out of reach of children. In case of accidental overdose, contact a medical professional or contact a poison control center immediately

Section 51945-4

comfort for teething label.jpg

Warnings:

Do not use for more than 7 days unless directed by a physician. Stop use and ask a doctor if

  • symptoms do not improve in 7 days
  • swelling, rash, or fever develops
  • irritiation, pain or redness persists or worsens

If pregnant or nursing, ask a doctor before use

Indications:

For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething.

Directions for Use:

Do not use if printed neck seal is broken or missing use only as directed. For infants 4 months and older: give 4 drops under the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours or as recommended by a doctor.

Inactive Ingredients

USP Purified water, Vegetable glycerine

Ingredients, Active:

Chamomilla (Chamomile) 3X, Arnica montana (Arnica) 6X, Calcarea phosphorica (Calcium phosphate)6x, Kreosotum (Creosote) 6X, Magensia phosphorica (Magnesium phosphate) 6X, Rheum (Rhubarb) 6X.

Comments Or Questions

Health for Kids Shelbourne Falls, MA 01370 USA

1-800-255-4463

www.herbsforkids.com


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, contact a medical professional or contact a poison control center immediately

Section 51945-4 (51945-4)

comfort for teething label.jpg

Warnings:

Do not use for more than 7 days unless directed by a physician. Stop use and ask a doctor if

  • symptoms do not improve in 7 days
  • swelling, rash, or fever develops
  • irritiation, pain or redness persists or worsens

If pregnant or nursing, ask a doctor before use

Indications:

For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething.

Directions for Use:

Do not use if printed neck seal is broken or missing use only as directed. For infants 4 months and older: give 4 drops under the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours or as recommended by a doctor.

Inactive Ingredients (Inactive ingredients)

USP Purified water, Vegetable glycerine

Ingredients, Active:

Chamomilla (Chamomile) 3X, Arnica montana (Arnica) 6X, Calcarea phosphorica (Calcium phosphate)6x, Kreosotum (Creosote) 6X, Magensia phosphorica (Magnesium phosphate) 6X, Rheum (Rhubarb) 6X.

Comments Or Questions (Comments or Questions)

Health for Kids Shelbourne Falls, MA 01370 USA

1-800-255-4463

www.herbsforkids.com


Advanced Ingredient Data


Raw Label Data

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