Other
Drug Facts
Cough Baby Syrup
FDA Label NDC 54973-3154
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Cough Baby (NDC 54973-3154). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, stop use and ask a doctor if, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. | |
| Bryonia Alba 6X HPUS | dry cough |
| Causticum 6X HPUS | hoarse cough |
| Drosera Rotundifolia 6X HPUS | barking cough |
| Ipecacuanha 6X HPUS | gagging cough |
| Phosphorus 12X HPUS | tight cough |
| Rumex Crispus 6X HPUS | dry cough |
| Spongia Tosta 6X HPUS | tickling cough |
Uses
Temporarily relieves the symptoms of simple, dry, tight or tickling coughs due to 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 48 hours 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 the 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 54973-3154-2
HOMEOPATHIC
Ages
6 months+
SINCE 1903
Hyland's®
Baby
Natural
Relief
Cough
Syrup
RELIEF OF COUGHS
DUE TO COLDS*
▶ No Alcohol, Artificial Flavors,
Dyes or Parabens
4 FL. OZ. (118 mL)
* Please review the disclaimer below.
