Otc - Purpose
Sleeplessness, Congestion, Runny Nose, Sore Throat, Cough, Post Nasal Drip
Kids Cold And Cough Daytime Grape Flavor Liquid
FDA Label NDC 54973-4110
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 Kids Cold And Cough Daytime Grape Flavor (NDC 54973-4110). 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, uses, sore throat warning, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breastfeeding, directions, 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 |
"HPUS" is the Homeopathic Pharmacopoeia of the United States.
| 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 |
"HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses
■ Helps temporarily relieve symptoms of common cold in children, including:
■ runny nose ■ sore throat ■ sneezing ■ cough
■ post nasal drip ■ nasal or chest congestion
■ Helps temporarily relieve symptoms of common cold in children at night, including:
■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat
■ nasal or chest congestion ■ occasional sleeplessness
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.
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.
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).
■ 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).
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.
■ 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.
If Pregnant Or Breastfeeding
ask a health professional before use.
Ask a health professional before use.
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 4 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 4 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?
www.hylands.com or [email protected]
Principal Display Panel
Hyland's
NATURALS™
Cold & Cough
COMBO PACK
NO ALCOHOL, SUGAR, PARABENS or DYES
| DAYTIME | NIGHTTIME |
| Congestion | Sleeplessness |
| Runny Nose | Congestion |
| Sore Throat | Runny Nose |
| Cough | Sore Throat |
| Post Nasal Drip | Cough |
| Post Nasal Drip |
4 - 12 YEARS
NATURAL
GRAPE FLAVOR
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)
HOMEOPATHIC
* Please review the disclaimer below.
