Baby Oral Pain Relief: Homeopathic Product Information

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

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:

■ gum sensitivity ■ swelling or soreness of gums ■ irritability

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 until relieved.

Children 6 months

to 3 years

Dissolve 2 tablets on tongue every 15 minutes

for 4 doses, then hourly until relieved.

Hyland’s Baby Oral Pain Relief tablets are very soft and will dissolve instantly

in the mouth.

Drug Facts (continued)

Other information

■ Do not use if imprinted “SEALED FOR YOUR PROTECTION” tamper-evident bottle cap band 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

HOMEOPATHIC

NDC 54973-3315-1

0+

MONTHS

NEW

LOOK

BABY

SINCE 1903

Hyland’s

DAYTIME

Oral Pain

Relief*

Relieves oral discomfort,

pain, irritability and swelling

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 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 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
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 6 [hp_X] in 1 g
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 30 [hp_X] in 1 g
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 12 [hp_X] in 1 g
FERRUM PHOSPHORICUM (FERRUM PHOSPHORICUM) FERRUM PHOSPHORICUM 12 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)
Product Characteristics
Color white Score no score
Shape ROUND Size 5mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3315-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 125 g in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3315-1)
2 NDC:54973-3315-3 6 g in 1 PACKET None
3 NDC:54973-3315-7 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 80 g in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3315-7)
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 (54973-3315), pack (54973-3315), label (54973-3315)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 080253323 manufacture (54973-3315), pack (54973-3315), label (54973-3315)

Revised: 11/2020 HYLAND’S

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