BABY GUM RELIEF- calcium fluoride, chamomile, ferrum phosphoricum, oyster shell calcium carbonate, crude, podophyllum and tribasic calcium phosphate tablet, orally disintegrating

BABY GUM RELIEF by

Drug Labeling and Warnings

BABY GUM RELIEF by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses1

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

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

1 Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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.

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

Directions

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

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

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.SimilasanUSA.com

SPL UNCLASSIFIED SECTION

Distributed by:
Similasan Corp., Highlands Ranch, CO 80129

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)

INGREDIENTS AND APPEARANCE

BABY GUM RELIEF 
calcium fluoride, chamomile, ferrum phosphoricum, oyster shell calcium carbonate, crude, podophyllum and tribasic calcium phosphate tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-502
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	12 [hp_X]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	12 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	8 [hp_X]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3)	PODOPHYLLUM	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
MANNITOL (UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-502-26	1 in 1 BOX	06/15/2018
1		135 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		06/15/2018

Labeler - Similasan Corporation (111566530)