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 54973-3379
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 54973-3379). 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, otc - pregnancy or breast feeding, otc - ask doctor, otc - keep out of reach of children, otc - do not use, 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.
A persistent cough may be a sign of a serious condition.
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.
HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
A persistent cough may be a sign of a serious condition.
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.
In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
*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
Otc - Pregnancy Or Breast Feeding
As with any drug, ask a doctor before use if pregnant or breast-feeding.
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Otc - Ask Doctor
Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection develops. ■ symptoms are accompanied by a high fever (over 101°F). ■ cough tends to recur or is accompanied by a high fever, rash or persistent headache.
Keep this and all medications out of the reach
Consult a physician if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection develops.
■ symptoms are accompanied by a high fever (over 101°F). ■ cough tends to recur or is accompanied by a high fever, rash or persistent headache.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
Keep this and all medications out of the reach of children.
Otc - Do Not Use
Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.
Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.
Overdosage
In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
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.
- 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 |
Dosage & Administration
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). |
Other Information
■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
■ The inner packaged bottle is child-resistant.
■ Store at room temperature.
■ Do not refrigerate.
■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
■ The inner packaged bottle is child-resistant.
■ Store at room temperature.
■ Do not refrigerate.
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 Or Comments?
(800) 624-9659
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)
Principal Display Panel - Kit Carton
VALUE PACK
HOMEOPATHIC
NDC 54973-3379-1
2-12
YEARS
NEW
LOOK
4 KIDS
SINCE 1903
Hyland's
Cold & Cough*
DAYTIME
Relieves congestion,
runny nose, sore throat,
sneezing, cough and
post nasal drip
NIGHTTIME
Relieves congestion, runny
nose, sore throat, sneezing,
cough, post nasal drip and
occasional sleeplessness
NATURAL
GRAPE
FLAVOR
NO ALCOHOL, PARABENS,
SUGAR or DYES
NATURAL
RELIEF
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)
TOTAL 8 FL. OZ. (236 mL)
*SEE NOTE ON SIDE
PANEL BELOW DRUG FACTS
* Please review the disclaimer below.
