Otc - Purpose
Temporarily relieve symptoms of common cold in children, including: cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat
Kids Cough And Mucus Daytime Grape Flavor Liquid
FDA Label NDC 54973-4113
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 Daytime Grape Flavor (NDC 54973-4113). 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 | |
| Antimonium Tartaricum 15X HPUS............................................... | cough | |
| Bryonia Alba 15X HPUS............................................................... | sore throat, mucus in throat, cough | |
| Ferrum Phosphoricum 12X HPUS ............................................... | mucus in throat, cough | |
| Hepar Sulph Calc 12X HPUS....................................................... | mucus in chest, cough | |
| 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
■ Helps temporarily relieve symptoms of common cold in children, including: ■ cough ■ runny nose ■ sneezing ■ sore throat
■ chest or nasal congestion ■ mucus in chest or throat
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 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). |
Inactive Ingredients
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™
•Kids•
Cough &
Mucus
DAYTIME
NO, ALCOHOL, SUGAR,
PARABENS or DYES
Cough
Mucus
Congestion
Runny Nose
EFFECTIVE
MUCUS
RELIEF
4 -12
YEARS
NATURAL
GRAPE FLAVOR
4 FL. OZ. (118 mL)
HOMEOPATHIC
Carton (Cmckf14oz Carton)
* Please review the disclaimer below.
