Baby Nighttime Oral Pain Relief Tablet
FDA Label NDC 54973-3324

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyland' Inc. for the product Baby Nighttime Oral Pain Relief (NDC 54973-3324). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, uses, warnings, consult a physician if, otc - keep out of reach of children, tamper evident, in case of emergency, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Uses

→ Warnings

→ Consult A Physician If

→ Otc - Keep Out Of Reach Of Children

→ Tamper Evident

→ In Case Of Emergency

→ Directions

→ Inactive Ingredient

→ Questions Or Comments?

→ Otc - Purpose

→ Principal Display Panel-125 Tablet Carton

Otc - Active Ingredient

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 the symptoms of gum sensitivity, swelling or soreness of gums, and occasional sleeplessness due to oral discomfort.

Warnings

Do not use • more than directed  • if your child has a known allergy to any ingredient in this product.

Consult A Physician If

• symptoms persist for more than 72 hours or worsen

• if swelling increases, rash or fever develops 

• Irritation, pain or redness persists or worsens.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Tamper Evident

Do not use if imprinted tamper band is broken or missing.

In Case Of Emergency

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 of age: If child is restless or wakeful during the night, dissolve 1 tablet on tongue every 15 minutes for

4 doses, then hourly until relieved.

Children 6 months to 3 years of age: If child is restless or wakeful during the night,dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

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

Inactive Ingredient

Acacia Gum, Lactose.

Questions Or Comments?

(800) 624-9659

Otc - Purpose

Oral Pain Relief

Principal Display Panel-125 Tablet Carton

NDC 54973-3324-1

HOMEOPATHIC

New!

SINCE 1903

Hyland's^®

Baby

Natural

Relief

Nighttime

Oral Pain

Relief

RELIEF OF PAIN,

IRRITABILITY, SWELLING, AND

OCCASIONAL SLEEPLESSNESS

DUE TO ORAL DISCOMFORT*

► No Belladonna, Benzocaine, Artificial Flavors,

Dyes or Parabens

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

* Please review the disclaimer below.

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