Drug Facts

Active ingredients	Purpose
Arnica Montana 30X HPUS	sore, sensitive or swelling gums
Calcarea Carbonica 12X HPUS	teething, sore, sensitive or swelling gums
Calcarea Phosphorica 12X HPUS	teething, sensitive, swelling gums, oral pain
Chamomilla 12X HPUS	sore, sensitive or swelling gums
Coffea Cruda 6X HPUS	oral pain, irritability
Ferrum Phosphoricum 12X HPUS	oral discomfort, swelling gums

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including:
■ teething ■ gum sensitivity ■ swelling or soreness of gums ■ irritability

Warnings

Stop use and ask a doctor if

■ symptoms persist for more than 72 hours or worsen. ■ swelling increases; nasal congestion, rash or fever is present or develops.

■ irritation, pain or redness persists or worsens.

Keep out of reach of children

Directions

■ Use as directed.

Children under 6 months	At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved.
Children 6 months to under 3 years	At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Inactive ingredients

Acacia Gum, Lactose.

Questions?

www.hylands.com or care@hylands.com

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,
NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability

Principal Display Panel

Hyland's

NATURALS™

•baby•

Oral Pain

Relief*

DAYTIME

NO BENZOCAINE,

DYES or PARABENS

Teething Pain
Oral Discomfort
Irritability
Swelling

0+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

carton

BABY ORAL PAIN RELIEF
oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3315
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X] in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X] in 1 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X] in 1 g
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	12 [hp_X] in 1 g

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3315-1	1 in 1 CARTON	08/17/2017
1		125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:54973-3315-3	6 g in 1 PACKET; Type 0: Not a Combination Product	08/17/2017	12/27/2021
3	NDC:54973-3315-7	1 in 1 CARTON	08/17/2017
3		80 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Hyland' Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc.		008316655	manufacture(54973-3315) , pack(54973-3315) , label(54973-3315)

Hyland's Naturals Baby Oral Pain Relief Daytime