Baby Orajel Naturals by Church & Dwight Canada Corp. / Church & Dwight Co., Inc. Baby Orajel Naturals

Baby Orajel Naturals by

Drug Labeling and Warnings

Baby Orajel Naturals by is a Homeopathic medication manufactured, distributed, or labeled by Church & Dwight Canada Corp., Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF- calcarea phosphorica, coffea cruda, chamomilla tablet, orally disintegrating 
Church & Dwight Canada Corp.

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 Orajel Naturals

Active Ingredient

Calcarea phosphorica, 3xHPUS
Coffea Cruda, 3xHPUS
Chamomilla, 3XHPUS

Purpose

Supports dentition
Wakefulness and diuresis
Irritability

Uses

  • temporarily relieves the simple symptoms of restlessness and wakeful irritability due to cutting teeth
  • for children under age 2, consult with your physician or pediatrician


   

Warnings

Stop use and ask a doctor if

  • symptoms persist for more than 7 days, if irritation persists, or if inflammation, fever or infection develops

Keep out of reach of children.

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Directions

  • dissolve 2-3 tablets (1 at a time) under baby's tongue or in a teaspoon of water prior to being given to baby
  • can give 2-3 tablets every hour up to 4 times per day or as recommended by a licensed health care professional

Other information

  • do not use if seal is cut or torn prior to opening

Inactive Ingredients

cellulose, lactose, magnesium stearate

Questions or comments?

call us at 1-800-952-5080 M-F 9zm-5pm ET or visit our website at www.orajelnaturals.com

Carton Image

Number 1 TEETHING BRAND

used by Pediatricians

NDC-10237-903-12

Baby

Orajel

Naturals

for Teething Pain Relief

teething tablets

HELPS RELIEVE TEETHING DISCOMFORT

QUICK DISSOLVE Benzocaine-Free

TABLETS Dye-Free

Alcohol-Free

HOMEOPATHIC

125 TABLETS

ORAL PAIN RELIEVER FOR TEETHING

BOJFC-32371-06

BABY ORAJEL NATURALS  FOR TEETHING PAIN RELIEF
calcarea phosphorica, coffea cruda, chamomilla tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62864-903
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE3 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62864-903-001 in 1 CARTON06/15/201109/24/2018
1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 62864-903-121 in 1 CARTON06/15/201109/24/2018
2125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/15/201109/24/2018
Labeler - Church & Dwight Canada Corp. (253933600)
Registrant - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Canada Corp.253933600manufacture(62864-903)

Revised: 12/2019
 
Church & Dwight Canada Corp.