FDA Label for Cold And Cough
View Indications, Usage & Precautions
Cold And Cough Product Label
The following document was submitted to the FDA by the labeler of this product �wal-mart Stores, 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.
Otc - Purpose
Active ingredients | Purpose |
Allium Cepa 6X HPUS | watery/runny nose, cold, hacking cough, sore 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 |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Active ingredients | Purpose |
Allium Cepa 6X HPUS | watery/runny nose, cold, hacking cough, sore 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 |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
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.
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 high fever (101˚F)
Cough tends to recur or is accompanied by high ever, rash or persistent headache Keep this and all medications out of t
Consult a physician if:
Symptoms persist for more than 7 days or worsen
Inflammation, fever or infection develops
Symptoms are accompanied by high fever (101˚F)
Cough tends to recur or is accompanied by 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.
Other
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 medical professional.
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.
The inner packaged bottle is child-resistant. In case of emergency, 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.
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.
The inner packaged bottle is child-resistant. In case of emergency, contact a medical professional or Poison Control Center immediately.
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.
Directions
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 | 5mL or 1 teaspoon up to 6 times per day (every 4 hours) |
Children 6 years to under 12 years | 10mL or 2 teaspoons up to 6 times per day (every 4 hours) |
Adults and children 12 years and over | 15mL or 3 teaspoons up to 6 times per day (every 4 hours) |
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 | 5mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessar |
Children 6 years to under 12 years | 10mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary |
Adults and children 12 years and over | 15mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary |
Inactive Ingredients
Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Primary Principal Display Panel - Children's Cold & Cough Day & Night Twin Pack Carton
DAY & NIGHT TWIN PACK
NDC 49035-95-01
Equate™
Compare to
Hyland’s 4 Kids
Cold ‘n Cough
Value Pack
Homeopathic
Children's Cold & Cough*
Daytime
Ages 2 to12 years
For Temporary Relief of:
Nasal congestion
Runny nose
Sore throat
Sneezing
Cough
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Alcohol free, Sugar free, Dye free
4 FL OZ (118mL) Daytime
8 FL OZ (236mL) TOTAL
Homeopathic
Children's Cold & Cough*
Nighttime
Ages 2 to12 years
For Temporary Relief of:
Chest congestion
Occasional sleeplessness
Runny nose
Sore throat
Sneezing
Cough
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
4 FL OZ (118mL) Nighttime
* Please review the disclaimer below.