Otc - Purpose
Temporarily relieves symptoms of common cold in children at night, including cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat, occasional sleeplessness
Kids Cough And Mucus Nighttime Grape Flavor Liquid
FDA Label NDC 54973-4057
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 Cough And Mucus Nighttime Grape Flavor (NDC 54973-4057). 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, active ingredients, 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
Active Ingredients
| Active ingredients | Purpose |
| Antimonium Tartaricum 15X HPUS | cough |
| Bryonia Alba 15X HPUS | sore throat, mucus in throat, cough |
| Chamomilla 6X HPUS | occasional sleeplessness |
| Ferrum Phosphoricum 12X HPUS | mucus in throat, cough |
| Hepar Sulph Calc 12X HPUS | mucus in chest, cough |
| Hydrastis Canadensis 15X HPUS | occasional sleeplessness
due to mucus in throat |
| Ipecacuanha 12X HPUS | cough, sore throat |
| Phosphorus 15X HPUS | runny nose, chest or nasal congestion |
| Pulsatilla 12X HPUS | mucus in chest or throat, cough, sneezing |
| Rumex Crispus 6X HPUS | runny nose, sneezing |
"HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses
Temporarily relieves symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ sneezing ■ sore throat
■ chest or nasal congestion ■ mucus in chest or throat ■ 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.
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).
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.
If Pregnant Or Breastfeeding
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 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.
Questions?
www.hylands.com or (800) 624-9659
Package Label - 118 Ml Bottle Carton
Hyland's
NATURALS™
•Kids•
NEW
Cough &
Mucus*
NIGHTTIME
NO ALCOHOL, SUGAR,
PARABENS or DYES
Sleeplessness
Cough
Mucus
Congestion
Runny Nose
EFFECTIVE
MUCUS
RELIEF
2-12
YEARS
NATURAL
GRAPE FLAVOR
4 FL. OZ. (118 mL)
HOMEOPATHIC
* Please review the disclaimer below.
