Childrens Nighttime Cold And Cough
FDA Label NDC 49035-920

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc for the product Childrens Nighttime Cold And Cough (NDC 49035-920). 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, other, otc - do not use, directions, 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

→ Other

→ Otc - Do Not Use

→ Directions

→ Inactive Ingredients

→ Primary Principal Display Panel - Children's Cold & Cough Day & Night Twin Pack Carton

Otc - Purpose

Active ingredients	Purpose
Allium Cepa 6X HPUS	watery/runny nose, cold, hacking cough, sore throat
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 Pharmacopœia of the United States.

Active ingredients	Purpose
Allium Cepa 6X HPUS	watery/runny nose, cold, hacking cough, sore 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 Pharmacopœia of the United States.

Uses

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

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

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 high fever (101˚F)

 Cough tends to recur or is accompanied by high ever, rash or persistent headache Keep this and all medications out of t

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

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.

Other

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.

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.

The inner packaged bottle is child-resistant. In case of emergency, contact a medical professional or Poison Control Center immediately.

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 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.

The inner packaged bottle is child-resistant. In case of emergency, contact a medical professional or Poison Control Center immediately.

Otc - Do Not Use

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

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	5mL or 1 teaspoon up to 6 times per day (every 4 hours)
Children 6 years to under 12 years	10mL or 2 teaspoons up to 6 times per day (every 4 hours)
Adults and children 12 years and over	15mL or 3 teaspoons up to 6 times per day (every 4 hours)

 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	5mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessar
Children 6 years to under 12 years	10mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
Adults and children 12 years and over	15mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

Inactive Ingredients

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

Primary Principal Display Panel - Children's Cold & Cough Day & Night Twin Pack Carton

DAY & NIGHT TWIN PACK

NDC 49035-95-01

Equate™

Compare to

Hyland’s 4 Kids

Cold ‘n Cough

Value Pack

Homeopathic

Children's Cold & Cough*

Daytime

Ages 2 to12 years

For Temporary Relief of:

Nasal congestion

Runny nose

Sore throat

Sneezing

Cough

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Alcohol free, Sugar free, Dye free

4 FL OZ (118mL) Daytime

8 FL OZ (236mL) TOTAL

Homeopathic

Children's Cold & Cough*

Nighttime

Ages 2 to12 years

For Temporary Relief of:

Chest congestion

Occasional sleeplessness

Runny nose

Sore throat

Sneezing

Cough

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

4 FL OZ (118mL) Nighttime

* Please review the disclaimer below.

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