FDA Label for Baby Nighttime Mucus Plus Cold Relief
View Indications, Usage & Precautions
Baby Nighttime Mucus Plus Cold Relief 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.
Purpose
Relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness
Otc - Active Ingredient
Active ingredients | Purpose |
Allium Cepa 6X HPUS | runny nose with mucus, hacking cough, sore throat |
Bryonia Alba 6X HPUS | stubborn mucus in throat, cough with mucus |
Chamomilla 3X HPUS | occasional sleeplessness |
Coffea Cruda 3X HPUS | occasional sleeplessness |
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 mucus, chest congestion |
Pulsatilla 6X HPUS | accumulation of mucus, discharge of mucus, loose cough |
Rumex Crispus 6X HPUS | runny nose, sneezing |
Silicea 12X HPUS | nasal congestion |
Sulfur 12X HPUS | cough with thick mucus, chest congestion, nasal congestion |
Other
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses
■ Temporarily relieves symptoms of common cold in children at night, including: ■ accumulation of mucus in chest, throat or nose
■ cough with mucus ■ runny nose ■ sneezing ■ nasal or chest congestion ■ occasional sleeplessness
Sore Throat Warning:
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Ask A Doctor Before Use If You Have:
■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).
Stop Use And Ask A Doctor If:
■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.
Directions
■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter.
Children under 6 months | Ask a doctor before use. |
Children 6 months
to under 1 year | 2.5 mL at bedtime and every 6 hours
during the night until relieved. |
Children 1 year
to under 3 years | 5 mL at bedtime and every 4 hours
during the night until relieved. |
Inactive Ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions?
(800) 624-9659
Indications And Usage
Added bullet
Dosage And Administration (Directions)
■ Shake well before using.
■ Measure only with the dosing syringe provided.
■ Do not use dosing syringe with other products.
■ On dosing syringe, mL = milliliter.
Children under 6 months | Consult a physician. |
Children 6 months to under 1 year | 2.5 mL at bedtime and every 6 hours during the night until relieved. |
Children 1 year to 3 years | 5 mL at bedtime and every 4 hours during the night until relieved. |
Package Label - 4 Fl Oz (118 Ml) Bottle Carton
Hyland's
NATURALS™
•baby•
Mucus +
Cold Relief*
NIGHTTIME
NO SUGAR,
PARABEN or DYES
Sleeplessness
Mucus
Congestion
Runny Nose
Sneezing
Cough
6+ MONTHS
4 FL. OZ. (118 mL)
LESS THAN 0.2% ALCOHOL | HOMEOPATHIC
* Please review the disclaimer below.