Baby Orajel Naturals For Teething Pain Relief (Calcarea Phosphorica, Coffea Cruda, Chamomilla) Tablet, Orally Disintegrating [Church & Dwight Canada Corp.] -

BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF (CALCAREA PHOSPHORICA, COFFEA CRUDA, CHAMOMILLA) TABLET, ORALLY DISINTEGRATING [CHURCH & DWIGHT CANADA CORP.]
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NDC	62864-903-00, 62864-903-12
Set ID	669db639-3d20-49f8-aa8f-9bbb0c40cafd
Category	HUMAN OTC DRUG LABEL
Packager	Church & Dwight Canada Corp.
Generic Name
Product Class
Product Number
Application Number

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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

Top Carton Image

Bottom Carton Image

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	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]

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description
Packaging
1	NDC:62864-903-00	1 in 1 CARTON
1		125 in 1 BOTTLE, PLASTIC
2	NDC:62864-903-12	1 in 1 CARTON
2		125 in 1 BOTTLE, PLASTIC

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

Labeler - Church & Dwight Canada Corp. (253933600)

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

Name	Address	ID/FEI	Business Operations
Establishment
Church & Dwight Canada Corp.		253933600	manufacture

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Medic

BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF (CALCAREA PHOSPHORICA, COFFEA CRUDA, CHAMOMILLA) TABLET, ORALLY DISINTEGRATING [CHURCH & DWIGHT CANADA CORP.]

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