PEDIATRIC COUGH AND COLD MEDICINE- chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid
Preferred Pharmaceuticals, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Pediatric Cough & Cold Medicine
Active Ingredient: Chlorpheniramine maleate 1 mg (in each 5 mL)
Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL)
Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL)
Purpose of Chlorpheniramine maleate: Antihistamine
Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant
Purpose of Dextromethorphan hydrobromide: Cough Suppressant
Uses temporarily relieves common cold, hay fever or other upper respiratory allergy symptoms:
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- nasal congestion
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- runny nose
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- sneezing
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- cough
Warnings
Do not exceed recommended dosage.
Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if your child has
- •
- heart diseases
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- asthma
- •
- a breathing problem or a persistent or chronic cough
- •
- excessive phlegm (mucus)
- •
- cough that occurs with too much phlegm (mucus)
- •
- chronic bronchitis
When using this product your child may
- •
- become easily excited
- •
- get drowsy
- •
- sedatives, and tranquilizers may increase drowsiness
Directions
- •
- Dose may be repeated every 4 to 6 hours or as directed by a doctor
- •
- Do not exceed 4 doses in 24 - hour period.
|
AGE |
DOSE |
|
Children 6 to under 11 years |
2 teaspoonfuls (TSP) |
|
Children under 6 years |
DO NOT USE |
Other information
Store at room temperature 20°-25°C (68°-77°F). Do not use if tamper-evident band around cap is broken or missing.
| PEDIATRIC COUGH AND COLD MEDICINE
chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid |
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| Labeler - Preferred Pharmaceuticals, Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals, Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals, Inc. | 791119022 | RELABEL(68788-9769) | |