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 
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 Nighttime

Drug Facts

Active ingredientsPurpose
Arnica Montana 30X HPUSsore, sensitive or swelling gums
Calcarea Carbonica 12X HPUSteething, sore, sensitive or swelling gums
Calcarea Phosphorica 12X HPUSteething, sensitive, swelling gums, oral pain
Chamomilla 12X HPUSsore, sensitive or swelling gums
Coffea Cruda 6X HPUSoral pain, irritability
Ferrum Phosphoricum 12X HPUSoral discomfort, swelling gums
Magnesia Phosphorica 12X HPUSoral pain, occasional sleeplessness
Silicea 12X HPUSoral pain at night, occasional sleeplessness

"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 ■ occasional sleeplessness

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 as needed. If symptoms persist,
2 tablets every 4 hours during the night until relieved.
Children 6 months
to under 3 years
At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
3 tablets every 4 hours during the night 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, occasional sleeplessness.

Principal Display Panel

Hyland's

NATURALS

•baby•

Oral Pain

Relief*

NIGHTTIME

NO BENZOCAINE,

DYES or PARABENS

Sleeplessness

Teething Pain

Oral Discomfort

Irritability

Swelling

0+ Months

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

Carton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3324
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
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 g
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3324-11 in 1 CARTON08/17/2017
11 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3324-46 g in 1 PACKET; Type 0: Not a Combination Product08/17/201712/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/17/2017
Labeler - Hyland' Inc. (008316655)

Revised: 1/2023
Document Id: f278d60f-551e-08c2-e053-2a95a90ac358
Set id: 58ef86b7-5b38-1591-e053-2991aa0aa53e
Version: 11
Effective Time: 20230117
 
Hyland' Inc.