4 Kids Cold And Cough Nighttime Liquid
FDA Label NDC 54973-3375

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 Consumer Health Inc. for the product 4 Kids Cold And Cough Nighttime (NDC 54973-3375). 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 - purpose, uses, otc - pregnancy or breast feeding, otc - ask doctor, otc - keep out of reach of children, otc - do not use, other, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Purpose

→ Uses

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Ask Doctor

→ Otc - Keep Out Of Reach Of Children

→ Otc - Do Not Use

→ Other

→ Sore Throat Warning

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Primary Principal Display - 118 Ml Bottle Carton

Otc - Purpose

Active ingredients	Purpose
Allium Cepa 6X HPUS	watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS	sensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUS	occasional sleeplessness, restlessness
Hepar Sulph Calc 12X HPUS	cold, sneezing
Hydrastis 6X HPUS	rattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUS	dry cough, sore throat
Phosphorus 12X HPUS	hoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUS	moist cough, cold, nasal congestion
Sulphur 12X HPUS	chest congestion, nasal congestion, sneezing, runny nose

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

Uses

Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

Otc - Pregnancy Or Breast Feeding

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Otc - Ask Doctor

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.

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.

Otc - Do Not Use

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional.

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

Other

A persistent cough may be a sign of a serious condition.

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.

Sore Throat Warning

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.

Directions

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

Children 2 years

to under 6 years

5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary

Children 6 years

to under 12 years

10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary

Adults and

children 12 years

and over

15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

Inactive Ingredients

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

Questions Or Comments?

(800) 624-9659

Primary Principal Display - 118 Ml Bottle Carton

NDC 54973-3375-1

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland's

4 Kids

Cold'n

Cough*

NIGHTTIME

Chest Congestion

Occasional Sleeplessness

Runny Nose

Sneezing

Cough

ALCOHOL FREE

SUGAR FREE

DYE FREE

4 FL. OZ. (118 mL)

* Please review the disclaimer below.

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