FDA Label for 2 To 12 Years Childrens Cold And Mucus
View Indications, Usage & Precautions
2 To 12 Years Childrens Cold And Mucus Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid Hdgrts Corp. 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 Purposes
Bryonia Alba 6X HPUS ................................. stubborn mucus in throat, cough with yellowish mucus
Euphrasia Officinalis 6X HPUS ..................... cough with mucus in chest
Hepar Sulph Calc 12X HPUS ......................... cough up mucus, mucus rattle with cough, stubborn mucus in chest
Natrum Muriaticum 30X HPUS .................... .accumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUS .................................. cough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUS ........................................ accumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUS .............................. runny nose, sneezing
Silicea 12X HPUS ......................................... nasal congestion
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
LOOSENS MUCUS IN CHEST, THROAT AND NOSE
LOOSENS MUCUS IN CHEST, THROAT AND NOSE
Uses
- Temporarily relieves the symptoms of colds including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.
- Temporarily relieves the symptoms of the common cold in children especially at mght including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion, and 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.
- 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.
Consult a physician if:
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.
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 phlegm (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.
Other
A persistent cough may be a sign of a serious condition.
In case of emergency, contact a medical professional or Poison Control Center immediately.
A persistent cough may be a sign of a serious condition.
In case of emergency, contact a medical professional or Poison Control Center immediately.
- THIS INFORMATION IS BASED UPON TRADITIONAL HOMEOPATHIC PRACTICE. THESE HAVE NOT BEEN REVIEWED BY FOOD AND DRUG ADMINISTRATION
- TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND OR SEAL UNDER CAP IS BROKEN OR MISSING
- This product is not manufactured or distributed by Hyland's
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 | 1 teaspoon or 5 mL up to 6 times per day (every 4 hours) |
Children 6 years to under 12 years | 2 teaspoons or 10 mL up to 6 times per day (every 4 hours) |
Adults and children 12 years and over | 3 teaspoons or 15 mL up to 6 times per day (every 4 hours) |
Children 2 years to under 6 years | 1 teaspoon or 5 mL up to 6 times per day (every 4 hours) |
Children 6 years to under 12 years | 2 teaspoon or 10 mL up to 6 times per day (every 4 hours) |
Adults and children 12 years and over | 3 teaspoon or 15 mL up to 6 times per day (every 4 hours) |
Inactive Ingredients
Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Active Ingredients Purposes
Allium Cepa 6X HPUS ..................... runny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUS .................... stubborn mucus in throat, cough wilh yellowish mucus
Chamomilla 3X HPUS ..................... irritabilily, fussiness, occasional sleeplessness
Collea Cruda 3X HPUS .................... occasional sleeplessness, restlessness
Euphrasia Officinalis 6X HPUS .......... cough with mucus in chest
Hepar Sulph Calc 12X HPUS .............. cough up mucus, mucus rattle with cough, stubborn mucus in chest
Hydrastis 6X HPUS ........................... cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat
Natrum Muriaticum 6X HPUS ............ accumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUS ...................... cough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUS ........................... accumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUS ................... runny nose, sneezing
Silicea 12X HPUS ............................... nasal congestion
Sulphur 12X HPUS ............................ cough with thick mucus, chest congestion, nasal congestion
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Principal Display Panel
CHILDREN'S COLD & MUCUS
Sugar Free, Dye Free
Alcohol free
DAYTIME
Runny Nose
Mucus & Congestion
Cough
NIGHTTIME
Runny Nose
Mucus & Congestion
Occasional Sleeplessness
Cough
2-12 YEARS
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)
HOMEOPATHIC
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