FDA Label for Baby Mucus Plus Cold Relief Daytime And Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- CONSULT A PHYSICIAN IF
- KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
- DO NOT USE THIS PRODUCT FOR
- A PERSISTENT COUGH MAY BE A SIGN OF A SERIOUS CONDITION
- SORE THROAT WARNING
- OTC - DO NOT USE
- THE INNER PACKAGED BOTTLE IS CHILD-RESISTANT
- IN CASE OF EMERGENCY
- DIRECTIONS
- DRUG FACTS (CONTINUED)
- INACTIVE INGREDIENTS
- CONSULT A PHYSICIAN IF:
- KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- THE INNER PACKAGED BOTTLE IS CHILD-RESISTANT.
- QUESTIONS OR COMMENTS?
- OTHER
- PRIMARY DISPLAY PANEL - DAY & NIGHT VALUE PACK KIT
Baby Mucus Plus Cold Relief 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
Bryonia Alba 6X HPUS
Euphrasia Officinalis 6X HPUS
Hepar Sulph Calc 12X HPUS
Natrum Muriaticum 30X HPUS
Phosphorus 30X HPUS
Pulsatilla 6X HPUS
Rumex Crispus 6X HPUS
Silicea 12X HPUS
“HPUS” indicates that the active ingredients are in the
official Homeopathic Pharmacopœia of the United States.
Allium Cepa 6X HPUS
Bryonia Alba 6X HPUS
Chamomilla 3X HPUS
Coffea Cruda 3X HPUS
Euphrasia Officinalis 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
Phosphorus 30X HPUS
Pulsatilla 6X HPUS
Rumex Crispus 6X HPUS
Silicea 12X HPUS
Sulphur 12X HPUS
“HPUS” indicates that the active ingredients are in the
official Homeopathic Pharmacopœia of the United States.
Purpose
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
Allium Cepa 6X HPUS......runny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUS.............. stubborn mucus in throat, cough with yellowish mucus
Chamomilla 3X HPUS.......irritability, fussiness, occasional sleeplessness
Coffea 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 and sneezing
Silicea 12X HPUS.....................................nasal congestion
Sulphur 12X HPUS...............cough with thick mucus, chest congestion, nasal congestion
Uses
Temporarily relieves the symptoms of colds, including: • accumulation of mucus in chest, throat and nose • cough with mucus
• runny nose • sneezing • nasal congestion
Temporarily relieves the symptoms of colds,including: • accumulation of mucus in chest, throat and nose • cough with mucus
• runny nose • sneezing •nasal congestion • irritability • fussiness • occasional sleeplessness
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 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, emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.
persistent or chronic cough such as asthma, smoking, emphysema or if cough is accompanied by excessive mucus, unles 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.
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 cap band is broken or missing.
Do not use if imprinted tamper-evident bottle cap band is broken or missing.
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.
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
• Measure only with the dosing syringe provided
• Do not use dosing syringe with other products
• On dosing syringe, mL = milliliter, tsp = teaspoon
- Measure only with the dosing syringe provided
- Do not use dosing syringe with other products
- On dosing syringe, mL = milliliter, tsp = teaspoon
Children under 6 months of age | consult a licensed health care professional before using this product |
Children 6 months to under 1 year of age | 2.5 mL or ½ tsp at bedtime and every 6 hours during the night or as necessary |
Children 1 to 3 years of age | 5 mL or 1 tsp at bedtime and every 4 hours during the night or as necessary |
Drug Facts (Continued)
Children under 6 months of age | consult a licensed health care professional before using this product |
Children 6 months to under 1 year of age | 2.5 mL or ½ tsp up to 4 times daily (every 6 hours) |
Children 1 to 3 years of age | 5 mL or 1 tsp up to 6 times daily (every 4 hours) |
Inactive Ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
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.
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.
The Inner Packaged Bottle Is Child-Resistant.
The inner packaged bottle is child-resistant.
Questions Or Comments?
(800) 624-9659
Other
*CLAIMS BASED ON TRADITIONAL
HOMEOPATHIC PRACTICE, NOT ACCEPTED
MEDICAL EVIDENCE. NOT FDA EVALUATED.
Primary Display Panel - Day & Night Value Pack Kit
NDC 54973-3374-1
HOMEOPATHIC
Ages
6 months+
NATURAL
RELIEF
SINCE 1903
Hyland's
baby
Mucus + Cold Relief*
Day & Night Value Pack
Daytime
LOOSENS MUCUS,
RELIEF OF
CONGESTION,
RUNNY NOSE
AND COUGH
ALCOHOL FREE
4 FL. OZ. (118 mL) Daytime
Nighttime
LOOSENS MUCUS,
RELIEF OF
CONGESTION
AND OCCASIONAL
SLEEPLESSNESS
DUE TO COLDS
LESS THAN 0.2% ALCOHOL
4 FL. OZ. (118 mL) Nighttime
No Artificial Flavors, Dyes or Parabens
8 FL. OZ. (236 mL) TOTAL
* Please review the disclaimer below.