BABY TEETHING PLUS TOOTH SUPPORT- oyster shell calcium carbonate, crude, calcium fluoride, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, and podophyllum tablet, orally disintegrating

Baby Teething Plus Tooth Support by

Drug Labeling and Warnings

Baby Teething Plus Tooth Support 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

Calcarea carbonica 12X

Purpose

pain, difficult dentition

Active Ingredient

Calcarea fluorica 12X

Purpose

supports dental development

Active Ingredient

Calcarea phosphorica 12X

Purpose

supports dental development, pain, slow dentition

Active Ingredient

Chamomilla 8X

Purpose

swelling, irritability, restlessness, sleeplessness, red cheek/face

Active Ingredient

Ferrum phosphoricum 12X      

Purpose

fussiness or restlessness

Active Ingredient

Podophyllum peltatum 12X

Purpose

drooling, chewing on things, irritability

Uses:

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

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

Warnings:

• Initial exacerbation of symptoms may occur.
  
• 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.

Inactive Ingredients:

Kollidon CL, Mannitol, Sodium stearyl fumarate 

Questions?

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

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-500-26
Similasan®
Teething +
Tooth Support
BABY
135 Quick Dissolving
Tablets

INGREDIENTS AND APPEARANCE

BABY TEETHING PLUS TOOTH SUPPORT 
oyster shell calcium carbonate, crude, calcium fluoride, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, and podophyllum tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-500
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]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	12 [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
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: 59262-500-26	1 in 1 BOX
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		01/01/2015

Labeler - Similasan Corporation (111566530)

Establishment
Name	Address	ID/FEI	Business Operations
Similasan Corporation		111566530	MANUFACTURE(59262-500)