Drug Facts
Drug Facts
Cold And Cough 4 Kids Liquid
FDA Label NDC 54973-3075
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 Cold And Cough 4 Kids (NDC 54973-3075). 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 drug facts, otc - purpose, uses, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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, post nasal drip |
| 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 symptoms of common cold
in children, including:
■ runny nose ■ sore throat ■ sneezing
■ cough ■ post nasal drip
■ nasal or chest congestion
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Otc - Ask Doctor
Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema.
A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).
Otc - Stop Use
Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is
present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use
dosing cup with other products. ■ On dosing cup, mL = milliliter.
| Children 2 years
to under 6 years | 5 mL up to 6 times per day
(every 4 hours). |
| Children 6 years
to under 12 years | 10 mL up to 6 times per day
(every 4 hours). |
| Adults and children
12 years and over | 15 mL up to 6 times per day
(every 4 hours). |
Inactive Ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions Or Comments?
(800) 624-9659
Other Safety Information
DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
Indications And Usage
Uses
Temporarily relieves the symptoms of the common cold, including:
runny nose
sore throat
sneezing
cough
post nasal drip
nasal or chest congestion
Changes To Section Dosage And Administration "Directions"
Shake well before using.
Measure only with the dosing cup provided.
Do not use dosing cup with other products.
On dosing cup, mL = milliliter.
Children 6 years
to under 12 years
Adults and children
12 years and over
Children 2 years
to under 6 years
10 mL up to 6 times per day
(every 4 hours)
15 mL up to 6 times per day
(every 4 hours)
Package Label - Principal Display Panel
Hyland's
NATURALS™
•Kids•
Cold &
Cough
DAYTIME
NO ALCOHOL, SUGAR,
PARABENS or DYES*
Congestion
Runny Nose
Sore Throat
Cough
Post Nasal
Drip
2-12
YEARS
4 FL. OZ (118 mL)
HOMEOPATHIC
* Please review the disclaimer below.
