Baby Gum Relief

Drug Facts

Composition & Product

Active Ingredients

Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Fluoride Ion (8 [hp_X]) Calcium Cation Chamomile Ferrosoferric Phosphate Podophyllum

Inactive Ingredients

Crospovidone, Unspecified Mannitol Sodium Stearyl Fumarate

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 4 mm Score: 1

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2018-06-15

Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 55105-1

Active Ingredients	Purpose
Calcarea carbonica (Calcium) 12X	pain, difficult dentition
Calcarea fluorica (Calcium) 12X	supports dental development
Calcarea phosphorica (Calcium) 12X	supports dental development, pain, slow dentition
Chamomilla (Chamomile) 8X	swelling, irritability, restlessness, sleeplessness, red cheek/face
Ferrum phosphoricum 12X	pain
Podophyllum peltatum (May Apple) 12X	drooling, chewing on things, irritability, fussiness or restlessness

Warnings

According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly.
Do not exceed recommended dosage.
As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.

Directions

Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.

Questions?

Reach our representatives at 1-800-240-9780 or [email protected]. www.SimilasanUSA.com

Other Information

Active ingredients are manufactured according to homeopathic principles.

Do not use if tamper evident seal beneath cap is broken or missing.

For more information, see http://www.similasanUSA.com/about-homeopathy

Inactive Ingredients

Crospovidone, Mannitol, Sodium stearyl fumarate

Principal Display Panel 135 Tablet Bottle Box

NDC 59262-502-26

BELLADONNA

FREE

Similasan_®

Baby Gum

Relief

QUICK DISSOLVING TABLETS

Formulated with

NATURAL ACTIVE INGREDIENTS

BABY

Chamomile for Irritability*
Triple Calcium Blend Supports

Development of Healthy Teeth*
Benzocaine Free • Belladonna Free

HOMEOPATHIC

The Swiss Original

135 Quick Dissolving

Tablets (actual size)

Usesclaims Based On Traditional Homeopathic Practice, Not Accepted Medical Evidence. Not Fda Evaluated.

According to homeopathic principles, the active ingredients in this product:

temporarily relieve restlessness & irritability due to painful gums
support dental development

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)

Active Ingredients	Purpose
Calcarea carbonica (Calcium) 12X	pain, difficult dentition
Calcarea fluorica (Calcium) 12X	supports dental development
Calcarea phosphorica (Calcium) 12X	supports dental development, pain, slow dentition
Chamomilla (Chamomile) 8X	swelling, irritability, restlessness, sleeplessness, red cheek/face
Ferrum phosphoricum 12X	pain
Podophyllum peltatum (May Apple) 12X	drooling, chewing on things, irritability, fussiness or restlessness

Warnings

According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly.
Do not exceed recommended dosage.
As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.

Directions

Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.

Questions?

Reach our representatives at 1-800-240-9780 or [email protected]. www.SimilasanUSA.com

Other Information (Other information)

Active ingredients are manufactured according to homeopathic principles.

Do not use if tamper evident seal beneath cap is broken or missing.

For more information, see http://www.similasanUSA.com/about-homeopathy

Inactive Ingredients (Inactive ingredients)

Crospovidone, Mannitol, Sodium stearyl fumarate

Principal Display Panel 135 Tablet Bottle Box (PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Box)

NDC 59262-502-26

BELLADONNA

FREE

Similasan_®

Baby Gum

Relief

QUICK DISSOLVING TABLETS

Formulated with

NATURAL ACTIVE INGREDIENTS

BABY

Chamomile for Irritability*
Triple Calcium Blend Supports

Development of Healthy Teeth*
Benzocaine Free • Belladonna Free

HOMEOPATHIC

The Swiss Original

135 Quick Dissolving

Tablets (actual size)

Usesclaims Based On Traditional Homeopathic Practice, Not Accepted Medical Evidence. Not Fda Evaluated. (UsesClaims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.)

According to homeopathic principles, the active ingredients in this product:

temporarily relieve restlessness & irritability due to painful gums
support dental development

Advanced Ingredient Data

[{"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "unii": "2E32821G6I", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIM", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "FERROSOFERRIC PHOSPHATE", "unii": "91GQH8I5F7", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "PODOPHYLLUM", "unii": "2S713A4VP3", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "CROSPOVIDONE, UNSPECIFIED", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STEARYL FUMARATE", "unii": "7CV7WJK4UI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.", "55105-1": "Active Ingredients Purpose Calcarea carbonica (Calcium) 12X pain, difficult dentition Calcarea fluorica (Calcium) 12X supports dental development Calcarea phosphorica (Calcium) 12X supports dental development, pain, slow dentition Chamomilla (Chamomile) 8X swelling, irritability, restlessness, sleeplessness, red cheek/face Ferrum phosphoricum 12X pain Podophyllum peltatum (May Apple) 12X drooling, chewing on things, irritability, fussiness or restlessness", "Warnings": "According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms). Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly. Do not exceed recommended dosage. As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.", "Directions": "Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.", "Questions?": "Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.SimilasanUSA.com", "Other information": "Active ingredients are manufactured according to homeopathic principles. Do not use if tamper evident seal beneath cap is broken or missing. For more information, see http://www.similasanUSA.com/about-homeopathy", "Inactive ingredients": "Crospovidone, Mannitol, Sodium stearyl fumarate", "PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Box": "NDC 59262-502-26 BELLADONNA FREE Similasan ® Baby Gum Relief QUICK DISSOLVING TABLETS Formulated with NATURAL ACTIVE INGREDIENTS BABY Chamomile for Irritability* Triple Calcium Blend Supports Development of Healthy Teeth* Benzocaine Free • Belladonna Free HOMEOPATHIC The Swiss Original 135 Quick Dissolving Tablets (actual size)", "UsesClaims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.": "According to homeopathic principles, the active ingredients in this product: temporarily relieve restlessness & irritability due to painful gums support dental development"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information