FDA Label for Baby Nighttime Tiny Cold
View Indications, Usage & Precautions
Baby Nighttime Tiny Cold 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.
Other
Drug Facts
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. | |
| Chamomilla 6X HPUS | occasional sleeplessness |
| Eupatorium Perfoliatum 6X HPUS | headache, cough, sneezing |
| Euphrasia Officinalis 6X HPUS | runny eyes and nose |
| Gelsemium Sempervirens 6X HPUS | sneezing with stuffy nose |
| Kali Iodatum 6X HPUS | headache, runny eyes and nose |
Uses
Temporarily relieves the symptoms of runny nose and eyes, cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.
Do Not Use
- for persistent or chronic cough such as occurs with asthma, smoking or emphysema
- 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.
Stop Use And Ask A Doctor If
- symptoms persist for more than 7 days or worsen
- 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 reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately.
Directions
- 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 teaspoon up to 4 times daily (every 6 hours) |
| children 1 to 3 years of age | 5 mL or 1 teaspoon up to 6 times daily (every 4 hours) |
Other Information
- do not use if imprinted tamper band is broken or missing
- Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659
Inactive Ingredients
Citric Acid,Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - 118 Ml Bottle Carton
NDC 54973-3180-1
HOMEOPATHIC
Ages
6 months+
SINCE 1903
Hyland's
Baby
Natural
Relief
Nighttime
Tiny Cold
Syrup
RELIEF OF RUNNY NOSE,
CONGESTION AND
OCCASIONAL
SLEEPLESSNESS
DUE TO COLDS*
▶ No Alcohol, Artificial Flavors,
Dyes or Parabens
4 FL. OZ. (118 mL)
* Please review the disclaimer below.