Baby Nighttime Mucus Plus Cold Relief Liquid
FDA Label NDC 54973-3371

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's Inc. for the product Baby Nighttime Mucus Plus Cold Relief (NDC 54973-3371). 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 active ingredients, purpose, uses, consult a physician if, keep this and all medications out of the reach of children, do not use this product for, a persistent cough may be a sign of a serious condition, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Consult A Physician If

→ Keep This And All Medications Out Of The Reach Of Children

→ Do Not Use This Product For

→ A Persistent Cough May Be A Sign Of A Serious Condition

→ Sore Throat Warning

→ Otc - Do Not Use

→ The Inner Packaged Bottle Is Child-resistant

→ In Case Of Emergency

→ Directions

→ Drug Facts (continued)

→ Inactive Ingredients

→ Consult A Physician If:

→ Keep This And All Medications Out Of The Reach Of Children.

→ The Inner Packaged Bottle Is Child-resistant.

→ Questions Or Comments?

→ Other

→ Primary Display Panel - Day & Night Value Pack Kit

Active Ingredients

Bryonia Alba 6X HPUS

Euphrasia Officinalis 6X HPUS

Hepar Sulph Calc 12X HPUS

Natrum Muriaticum 30X HPUS

Phosphorus 30X HPUS

Pulsatilla 6X HPUS

Rumex Crispus 6X HPUS

Silicea 12X HPUS

“HPUS” indicates that the active ingredients are in the

official Homeopathic Pharmacopœia of the United States.

Allium Cepa 6X HPUS

Bryonia Alba 6X HPUS

Chamomilla 3X HPUS

Coffea Cruda 3X HPUS

Euphrasia Officinalis 6X HPUS

Hepar Sulph Calc 12X HPUS

Hydrastis 6X HPUS

Natrum Muriaticum 6X HPUS

Phosphorus 30X HPUS

Pulsatilla 6X HPUS

Rumex Crispus 6X HPUS

Silicea 12X HPUS

Sulphur 12X HPUS

“HPUS” indicates that the active ingredients are in the

official Homeopathic Pharmacopœia of the United States.

Purpose

Bryonia Alba 6X HPUS...stubborn mucus in throat, cough with yellowish mucus

Euphrasia Officinalis 6X HPUS...cough with mucus in chest

Hepar Sulph Calc 12X HPUS......cough up mucus, mucus rattle with cough, stubborn mucus in chest

Natrum Muriaticum 30X HPUS....accumulation of mucus in throat, cough up mucus

Phosphorus 30X HPUS.........cough with expectoration of yellow mucus, chest congestion

Pulsatilla 6X HPUS...accumulation of mucus, discharge of thick yellowish mucus, loose cough

Rumex Crispus 6X HPUS.................runny nose, sneezing

Silicea 12X HPUS...................................nasal congestion

Allium Cepa 6X HPUS......runny nose with mucus, hacking cough, sore throat

Bryonia Alba 6X HPUS.............. stubborn mucus in throat, cough with yellowish mucus

Chamomilla 3X HPUS.......irritability, fussiness, occasional sleeplessness

Coffea Cruda 3X HPUS...............occasional sleeplessness, restlessness

Euphrasia Officinalis 6X HPUS...cough with mucus in chest

Hepar Sulph Calc 12X HPUS...cough up mucus, mucus rattle with cough, stubborn mucus in chest

Hydrastis 6X HPUS.... cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat

Natrum Muriaticum 6X HPUS.......accumulation of mucus in throat, cough up mucus

Phosphorus 30X HPUS...........cough with expectoration of yellow mucus, chest congestion

Pulsatilla 6X HPUS...accumulation of mucus, discharge of thick yellowish mucus, loose cough

Rumex Crispus 6X HPUS............runny nose and sneezing

Silicea 12X HPUS.....................................nasal congestion

Sulphur 12X HPUS...............cough with thick mucus, chest congestion, nasal congestion

Uses

Temporarily relieves the symptoms of colds, including: • accumulation of mucus in chest, throat and nose • cough with mucus 

• runny nose • sneezing • nasal congestion

Temporarily relieves the symptoms of colds,including: • accumulation of mucus in chest, throat and nose • cough with mucus 

• runny nose • sneezing •nasal congestion • irritability • fussiness • occasional sleeplessness

Consult A Physician If

• symptoms persist for more than 7 days or worsen. • inflammation, fever or infection develops. • symptoms are accompanied by a high fever (over 101°F). • cough tends to recur or is accompanied by a high fever, rash or persistent headache.

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.

Do Not Use This Product For

persistent or chronic cough such as asthma, smoking, emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

persistent or chronic cough such as asthma, smoking, emphysema or if cough is accompanied by excessive mucus, unles directed by a licensed health care professional.

A Persistent Cough May Be A Sign Of A Serious Condition

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

Otc - Do Not Use

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

The Inner Packaged Bottle Is Child-Resistant

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

• Measure only with the dosing syringe provided

• Do not use dosing syringe with other products

• On dosing syringe, mL = milliliter, tsp = teaspoon

Measure only with the dosing syringe provided
Do not use dosing syringe with other products
On dosing syringe, mL = milliliter, tsp = teaspoon

Children under

6 months of age

consult a licensed health care professional

before using this product

Children 6 months to

under 1 year of age

2.5 mL or ½ tsp at bedtime and every

6 hours during the night or as necessary

Children 1 to 3

years of age

5 mL or 1 tsp at bedtime and every 4 hours

during the night or as necessary

Drug Facts (Continued)

Children under

6 months of age

consult a licensed health care

professional before using this

product

Children 6 months to

under 1 year of age

2.5 mL or ½ tsp up to

4 times daily (every 6 hours)

Children 1 to 3

years of age

5 mL or 1 tsp up to

6 times daily (every 4 hours)

Inactive Ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Consult A Physician If:

• symptoms persist for more than 7 days or worsen. • inflammation, fever or infection develops. • symptoms are accompanied by high fever (101°F). • cough tends to recur or is accompanied by high fever, rash or persistent headache.

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.

The Inner Packaged Bottle Is Child-Resistant.

The inner packaged bottle is child-resistant.

Questions Or Comments?

(800) 624-9659

Other

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT ACCEPTED

MEDICAL EVIDENCE. NOT FDA EVALUATED.

Primary Display Panel - Day & Night Value Pack Kit

NDC 54973-3374-1

HOMEOPATHIC

Ages

6 months+

NATURAL

RELIEF

SINCE 1903

Hyland's

baby

Mucus + Cold Relief*

Day & Night Value Pack

Daytime

LOOSENS MUCUS,

RELIEF OF

CONGESTION,

RUNNY NOSE

AND COUGH

ALCOHOL FREE

4 FL. OZ. (118 mL) Daytime

Nighttime

LOOSENS MUCUS,

RELIEF OF

CONGESTION

AND OCCASIONAL

SLEEPLESSNESS

DUE TO COLDS

LESS THAN 0.2% ALCOHOL

4 FL. OZ. (118 mL) Nighttime

No Artificial Flavors, Dyes or Parabens

8 FL. OZ. (236 mL) TOTAL

* Please review the disclaimer below.

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