FDA Label for Baby Cough Syrup
View Indications, Usage & Precautions
Baby Cough Syrup Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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 Hpus*
Drosera rotundifolia 6X
Bryonia alba 6X
Ipecacuanha 6X
Spongia tosta 6X
Causticum 6X
Phosphorus 12X
Rumex crispus 6X
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
Purpose
Drosera rotundifolia 6X................................ Barking cough
Bryonia alba 6X.......................................... Dry cough
Ipecacuanha 6X.......................................... Gagging cough
Spongia tosta 6X......................................... Tickling cough
Causticum 6X............................................. Hoarse cough
Phosphorus 12X.......................................... Tight cough
Rumex crispus 6X....................................... Dry cough
Uses
Temporarily relieves the symptoms of simple, dry, tight or tickling coughs due to colds in children.*
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
Warnings
Otc - Ask Doctor
As with any drug, ask a doctor before use if pregnant or nursing.
Stop use and ask a doctor if • symptoms persist for more than 48 hours or worsen • cough tends to recur or is accompanied by a 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 emergency or accidental overdose, contact a medical professional or a poison control center immediately.
Otc - Do Not Use
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.
Do not use if security seal is broken or missing.
Directions
Measure only with the dosing syringe provided.
Do not use dosing syringe with other products.
On dosing syringe, tsp = teaspoon.
Children under 6 months of age: Consult a licensed health care professional before using this product.
Children 6 months to 1 year of age: 2.5 ml or 1/2 teaspoon up to 4 times a day (every 6 hours), or as directed by a licensed health care professional.
Children 1 to 3 years of age: 5 ml or 1 teaspoon up to 6 times a day (every 4 hours), or as directed by a licensed health care professional.
Other Information
Store at room temperature (68°-77°F)
Inactive Ingredients
Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid
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