FDA Label for 4 Kids Cold And Cough Daytime And Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- OTC - PREGNANCY OR BREAST FEEDING
- CONSULT A PHYSICIAN IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- DO NOT USE THIS PRODUCT
- PERSISTENT COUGH
- SORE THROAT WARNING
- OTC - DO NOT USE
- OTHER
- DIRECTIONS
- INACTIVE INGREDIENTS
- CONSULT A PHYSICIAN
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - KIT CARTON
4 Kids Cold And Cough Daytime And Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Hyland�s Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Allium Cepa 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
Phosphorus 12X HPUS
Pulsatilla 6X HPUS
Sulphur 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Allium Cepa 6X HPUS
Chamomilla 6X HPUS
Coffea Cruda 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
Phosphorus 12X HPUS
Pulsatilla 6X HPUS
Sulphur 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
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, nasal congestion
Sulphur 12X HPUS......................chest congestion, nasal congestion, sneezing, runny nose
Allium Cepa 6X HPUS ..........watery/runny nose, cold,hacking cough, painful throat
Chamomilla 6X HPUS ......... sensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUS........occasional sleeplessness, restlessness
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, nasal congestion
Sulphur 12X HPUS .........................chest congestion,nasal congestion, sneezing, runny nose
Uses
Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.
Temporarily relieves the symptoms of the common cold including cough, runny nose,
sneezing, nasal and chest congestion, and sore throat with accompanying 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.
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. In case of accidental overdose, contact a medical
professional or Poison Control Center immediately.
Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical
professional or Poison Control Center immediately.
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.
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.
Persistent Cough
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.
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea,and vomiting may be serious. Consult a doctor promptly.
Otc - Do Not Use
Do not use if imprinted tamper-evident bottle band is
broken or missing.
Do not use if imprinted tamper-evident bottle band is
broken or missing.
Other
The inner packaged bottle is child-resistant. In case of emergency, 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.
A persistent cough may be a sign of a serious condition.
The inner packaged bottle is child-resistant. In case of emergency, 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.
Directions
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, mL = milliliter, tsp = teaspoon
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, mL = milliliter, tsp = teaspoon
Children 2 years to under 6 years | 5 mL or 1 teaspoon up to
6 times per day (every 4 hours) |
Children 6 years to under 12 years | 10 mL or 2 teaspoons up to 6 times per day (every 4 hours) |
Adults and children 12 years and over | 15 mL or 3 teaspoons up to 6 times per day (every 4 hours) |
Children 2 years to under 6 years | 5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary |
Children 6 years to under 12 years | 10 mL or 2 teaspoons at
bedtime and every 4 hours during the night or as necessary |
Adults and children 12 years and over | 15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary |
Inactive Ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Consult A Physician
- 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.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - Kit Carton
NDC-54973-3378-1
HOMEOPATHIC
NATURAL
RELIEF
SINCE 1903
Hyland's
4 Kids
Cold ’n Cough*
Day & Night Value Pack
DAYTIME
Nasal Congestion
Runny Nose
Sore Throat
Sneezing
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL) Daytime
NIGHTTIME
Chest Congestion
Occasional Sleeplessness
Runny Nose
Sore Throat
Sneezing
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL) Nighttime
8 FL. OZ. (236 mL) TOTAL
* Please review the disclaimer below.