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'S

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

Purpose

Relieves oral discomfort, pain, irritability, swelling and occasional sleeplessness

Drug Facts

Active ingredients

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

Magnesia Phosphorica 12X HPUS

oral pain, occasional sleeplessness

Silicea 12X HPUS

oral pain at night, occasional sleeplessness

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

■ Temporarily relieves symptoms of oral pain or discomfort in children at night, including:

■ 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.

Keep this and all medications out of the 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 (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

PACKAGE LABEL

Hyland's

NATURALS

baby

Oral Pain

Relief

NO BENZOCAINE,
DYES or PARABENS

Sleeplessness
Teething Pain
Oral Discomfort
Irritability
Swelling

0+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

1

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'S (028570695)
Registrant - STANDARD HOMEOPATHIC COMPANY (HYLAND'S) (008316655)
Establishment
NameAddressID/FEIBusiness Operations
STANDARD HOMEOPATHIC COMPANY008316655manufacture(54973-3324) , pack(54973-3324) , label(54973-3324)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company080253323manufacture(54973-3324) , pack(54973-3324) , label(54973-3324)

Revised: 12/2021
Document Id: d426764b-0c13-6fb8-e053-2a95a90a73bc
Set id: 58ef86b7-5b38-1591-e053-2991aa0aa53e
Version: 9
Effective Time: 20211227
 
HYLAND'S