BABY NIGHTTIME ORAL PAIN RELIEF- arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude tablet

Baby Nighttime Oral Pain Relief by

Drug Labeling and Warnings

Baby Nighttime Oral Pain Relief by is a Homeopathic medication manufactured, distributed, or labeled by Hyland' Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Arnica Montana 30X HPUS

Calcarea Carbonica 12X HPUS

Calcarea Phosphorica 12X HPUS

Chamomilla 12X HPUS

Coffea Cruda 6X HPUS

Ferrum Phosphoricum 12X HPUS

Magnesia Phosphorica 12X HPUS

Silicea 12X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Purpose

sore, sensitive or swelling gums

sore, sensitive or swelling gums

sensitive, swelling gums, oral pain

sore, sensitive or swelling gums

oral pain, irritability

oral discomfort, swelling gums

oral pain, occasional sleeplessness

oral pain at night, occasional sleeplessness

Uses

Temporarily relieves the symptoms of: gum sensitivity swelling or soreness of gums occasional sleeplessness due to oral pain or discomfort

Warnings

Do not use: more than directed  if your child has a known allergy to any ingredient in this product.

Consult a physician if: symptoms persist for more than 72 hours or worsen. swelling increases, rash or fever develops.

irritation, pain or redness persists or worsens.

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

The inner packaged bottle is child-resistant.In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

• Children under 6 months of age:

  If child is restless or wakeful during the night,

  dissolve 1 tablet on tongue every 15 minutes for

  4 doses, then hourly until relieved.

• Children 6 months to 3 years of age:

  If child is restless or wakeful during the night, dissolve

  2 tablets on tongue every 15 minutes for 4 doses, then

  hourly until relieved.

Hyland’s Baby Nighttime Oral Pain Relief Tablets are very soft and will dissolve

instantly in the mouth.

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL-125 TABLET BOTTLE CARTON

NDC: 54973-3324-1

HOMEOPATHIC

Natural

Relief

SINCE 1903

Hyland's

Baby

Nighttime

Oral Pain

Relief*

RELIEF OF PAIN,

IRRITABILITY, SWELLING, AND

OCCASIONAL SLEEPLESSNESS

DUE TO ORAL DISCOMFORT

► No Belladonna, Benzocaine, Artificial Flavors,

Dyes or Parabens

125 QUICK-DISSOLVING TABLETS

ACTUAL SIZE 65 MG

INGREDIENTS AND APPEARANCE

BABY NIGHTTIME ORAL PAIN RELIEF 
arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3324
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]  in 1 g
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	12 [hp_X]  in 1 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]  in 1 g
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]  in 1 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]  in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3324-1	1 in 1 CARTON	08/17/2017
1		1 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3324-4	6 g in 1 PACKET; Type 0: Not a Combination Product	08/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/17/2017

Labeler - HYLAND'S (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
STANDARD HOMEOPATHIC COMPANY		008316655	manufacture(54973-3324) , pack(54973-3324) , label(54973-3324)