2 To 12 Years Childrens Cold And Cough Day And Night Time
FDA Label NDC 11822-2233

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Hdgrts Corp for the product 2 To 12 Years Childrens Cold And Cough Day And Night Time (NDC 11822-2233). 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, other, uses, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - ask doctor, 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 - Active Ingredient

→ Other

→ Uses

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Otc - Ask Doctor

→ Otc - Do Not Use

→ Directions

→ Inactive Ingredients

→ Other Safety Information

→ Package Label - Kit Carton

Otc - Active Ingredient

Active ingredients	Purpose
Allium Cepa 6X HPUS	watery/runny nose, cold, hacking cough, painful 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

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

Other

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

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

THIS INFORMATION IS BASED UPON TRADITIONAL HOMEOPATHIC PRACTICE. THESE HAVE NOT BEEN REVIEWED BY FOOD AND DRUG ADMINISTRATION

Uses

temporarily relieves the symptoms of 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.

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 a poison control center immediately.

Otc - Ask Doctor

Consult a physician if:

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

Consult a physician if:

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

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 phlegm (mucus), unless directed by a licensed medical professional.

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.

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

Inactive Ingredients

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

Other Safety Information

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND OR SEAL UNDER CAP IS BROKEN OR MISSING

Package Label - Kit Carton

CHILDREN'S COLD & COUGH

Sugar Free, Dye Free

Alcohol free

DAYTIME

Cough
Nasal Congestion
Runny Nose
Sore Throat
Sneezing

NIGHTTIME

Cough
Sneezing
Runny Nose
Sleeplessness
Sore Throat

2-12 YEARS

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

Catronlabel (Cartonlabel)

* Please review the disclaimer below.

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