Baby Nighttime Oral Pain Relief: Homeopathic Product Information

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

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

Do not use more than directed.

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 emergency or accidental overdose, 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

Dissolve 1 tablet on tongue every 15 minutes for 4 doses,

then hourly during the night until relieved.

Children 6 months

to 3 years

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

then hourly during the night until relieved.

Hyland’s Baby Nighttime Oral Pain Relief Tablets are very soft and will dissolve instantly in the mouth.

Drug Facts (continued)

Other information

■ Do not use if imprinted “SEALEDforYOURPROTECTION” tamper-evident bottle mouth foil seal is broken or missing.

■ The inner packaged bottle is child-resistant.

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

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

PRINCIPAL DISPLAY PANEL

HOM EOPATHIC

NDC 54973-3324-1

0+

MONTHS

BABY

SINCE 1903

Hyland’s

Nighttime

Oral Pain

Relief*

Relieves oral discomfort, pain, irritability,

swelling and occasional sleeplessness

NO BELLADONNA or BENZOCAINE

NO ARTIFICIAL FLAVORS, DYES or PARABENS

NATURAL

RELIEF

125 QUICK-DISSOLVING TABLETS

*SEE NOTE ON SIDE

PANEL BELOW DRUG FACTS

Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] in 1 g
TRIBASIC CALCIUM PHOSPHATE (PHOSPHATE ION) TRIBASIC CALCIUM PHOSPHATE 12 [hp_X] in 1 g
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 12 [hp_X] in 1 g
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 12 [hp_X] in 1 g
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 30 [hp_X] in 1 g
FERROSOFERRIC PHOSPHATE (FERROSOFERRIC PHOSPHATE) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 1 g
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 6 [hp_X] in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)
ACACIA
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3324-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 1 g in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3324-1)
2 NDC:54973-3324-4 6 g in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/17/2017
Labeler — HYLAND’S (028570695)
Registrant — STANDARD HOMEOPATHIC COMPANY (HYLAND’S) (008316655)
Establishment
Name Address ID/FEI Operations
STANDARD HOMEOPATHIC COMPANY 008316655 manufacture (54973-3324), pack (54973-3324), label (54973-3324)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 080253323 manufacture (54973-3324), pack (54973-3324), label (54973-3324)

Revised: 11/2020 HYLAND’S

HomeoLabels.com provides trustworthy package insert and label information about marketed homeopathic remedies as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by HomeoLabels.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Main Sections

Homeopathy Information by RSS

We source our database directly from the FDA's central repository of homeopathic remedy labels and package inserts, under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.