BABY TEETHING- calcium phosphate, chamomile, coffea arabica fruit, and belladonna leaf tablet, soluble 
Hyland's, Inc.

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 Teething

Drug Facts

Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Calcarea Phosphorica 6X HPUSteething, dentition
Chamomilla 6X HPUSirritability
Coffea Cruda 6X HPUSsleeplessness
Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)redness and teething discomfort

Uses

Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth. Helps reduce redness and teething discomfort.

Warnings

Do not use:

  • more often than directed
  • for more than 7 days in a row unless directed by a doctor or dentist
  • if your child has a known allergy to any ingredient in this product

Stop use and ask a doctor if:

  • symptoms persist for more than 7 days or worsen
  • swelling, rash, or fever develops
  • irritation, pain, or redness persist or worsen

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

Children under 3 years of age

Dissolve 2 to 3 tablets on tongue 4 times daily.

  • If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child.
  • If the child is restless or wakeful, dissolve 2 tablets on tongue every hour for up to 6 doses.
  • Teething Tablets are very soft and dissolve almost instantly in the mouth.
  • Please note: if your child has been crying or upset, your child may fall asleep after using this product because the pain has been relieved and your child can rest.

Other information

  • do not use if imprinted tamper band is broken or missing
  • Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659

Inactive ingredients

Acacia Gum, Lactose N.F.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 135 Tablets Bottle Carton

NDC 54973-3127-1
HOMEOPATHIC

SINCE 1903
Hyland's ®
Baby

Natural
Relief

Teething
Tablets

FAST RELIEF OF PAIN AND
IRRITABILITY FROM TEETHING*

No Benzocaine, Artificial Flavors, Dyes or Parabens

135 QUICK-DISSOLVING TABLETS

PRINCIPAL DISPLAY PANEL - 135 Tablets Bottle Carton
BABY TEETHING 
calcium phosphate, chamomile, coffea arabica fruit, and belladonna leaf tablet, soluble
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3127
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE6 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT6 [hp_X]
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3127-11 in 1 CARTON07/11/201101/03/2017
1135 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3127-2250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/201101/03/2017
3NDC:54973-3127-340 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/201101/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/11/201101/03/2017
Labeler - Hyland's, Inc. (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(54973-3127) , pack(54973-3127)

Revised: 10/2017
 
Hyland's, Inc.