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

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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Hyland's Naturals Baby Oral Pain Relief Daytime

Relieves oral discomfort, pain, irritability and swelling

Drug Facts

Active ingredients

Purpose

Arnica Montana 30X HPUS

sore, sensitive or swelling gums

Calcarea Carbonica 12X HPUS

sore, sensitive or swelling gums

Calcarea Phosphorica 12X HPUS

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” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

■Temporarily relieves 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 monthsAt 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 (800) 624-9659

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

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3315
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 g
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE12 [hp_X]  in 1 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [hp_X]  in 1 g
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3315-11 in 1 CARTON08/17/2017
1125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3315-36 g in 1 PACKET; Type 0: Not a Combination Product08/17/201712/27/2021
3NDC:54973-3315-71 in 1 CARTON08/17/2017
380 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/17/2017
Labeler - Hyland' Inc. (008316655)

Revised: 11/2022
 
Hyland' Inc.