Otc - Purpose
Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness
4 Kids Cold And Cough Day And Night Grape Flavor Kit
FDA Label NDC 54973-4127
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 4 Kids Cold And Cough Day And Night Grape Flavor (NDC 54973-4127). 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, otc - active ingredient, other, uses, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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, post nasal drip |
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 | occasional sleeplessness |
Coffea Cruda 6X HPUS | occasional sleeplessness |
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 |
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.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
Uses
■ Temporarily relieves symptoms of common cold
in children, including:
■ runny nose ■ sore throat ■ sneezing
■ cough ■ post nasal drip
■ nasal or chest congestion
■ Temporarily relieves symptoms of common cold
in children at night, including:
■ cough ■ runny nose ■ post nasal drip
■ sneezing ■ nasal or chest congestion
■ sore throat ■ occasional sleeplessness
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.
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).
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.
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.
If pregnant or breastfeeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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). |
■ 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 at bedtime and every 4 hours
during the night until relieved. |
| Children 6 years
to under 12 years | 10 mL at bedtime and every 4 hours
during the night until relieved. |
| Adults and children
12 years and over | 15 mL at bedtime and every 4 hours
during the night until relieved. |
Inactive Ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.
Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.
Questions?
(800) 624-9659
Other Safety Information
DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
Indications And Usage
update:
Uses
- Temporarily relieves symptoms of common cold in children, including:
- runny nose
- sore throat
- sneezing
- cough
- post nasal drip
- nasal or chest congestion
Dosage And Administration
Directions
- 5 mL up to 6 times per day
- 10 mL up to 6 times per day
- 15 mL up to 6 times per day
(every 4 hours)
(every 4 hours)
(every 4 hours)
Package Label - Kit Carton
Hyland's
•KIDS•
Cold & Cough
COMBO PACK
NO ALCOHOL, SUGAR,
PARABENS or DYES
DAYTIME
Congestion
Runny Nose
Sore Throat
Cough
Post Nasal
Drip
NIGHTTIME
Sleeplessness
Congestion
Runny Nose
Sore Throat
Cough
Post Nasal
Drip
2-12 YEARS
NATURAL
GRAPE FLAVOR
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night) | TOTAL 8 FL. OZ. (236 ML)
HOMEOPATHIC
* Please review the disclaimer below.
