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

BABY ORAJEL NATURALS  FOR TEETHING PAIN RELIEF
calcarea phosphorica, coffea cruda, chamomilla tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62864-903
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	3 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62864-903-00	1 in 1 CARTON	06/15/2011	09/24/2018
1		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 62864-903-12	1 in 1 CARTON	06/15/2011	09/24/2018
2		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/15/2011	09/24/2018

Labeler - Church & Dwight Canada Corp. (253933600)

Registrant - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp.		253933600	manufacture(62864-903)

Revised: 12/2019

Document Id: 9b030bb3-ef64-5cfd-e053-2995a90ae205

34390-5

Set id: 669db639-3d20-49f8-aa8f-9bbb0c40cafd

Version: 10

Effective Time: 20191231

 

Church & Dwight Canada Corp.