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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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BABY GUM RELIEF

Drug Facts

Active IngredientsPurpose
Calcarea carbonica (Calcium) 12Xpain, difficult dentition
Calcarea fluorica (Calcium) 12Xsupports dental development
Calcarea phosphorica (Calcium) 12Xsupports dental development, pain, slow dentition
Chamomilla (Chamomile) 8Xswelling, irritability, restlessness, sleeplessness, red cheek/face
Ferrum phosphoricum 12Xpain
Podophyllum peltatum (May Apple) 12Xdrooling, chewing on things, irritability, fussiness or restlessness

Uses1

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


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

Warnings

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

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

HOMEOPATHIC
The Swiss Original

135 Quick Dissolving
Tablets (actual size)

PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Box
BABY GUM RELIEF 
calcium fluoride, chamomile, ferrum phosphoricum, oyster shell calcium carbonate, crude, podophyllum and tribasic calcium phosphate tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-502
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE8 [hp_X]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59262-502-261 in 1 BOX06/15/2018
1135 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC06/15/2018
Labeler - Similasan Corporation (111566530)

Revised: 8/2018
Document Id: b0b8413d-2d5b-4e27-a213-5573dd1e3e0d
Set id: 5d49e61d-7bd1-4211-bbad-80da9d7dfabf
Version: 2
Effective Time: 20180809
 
Similasan Corporation