FDA Label for Children Cough And Cold
View Indications, Usage & Precautions
Children Cough And Cold Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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.
Otc - Active Ingredient
Active ingredient (in each 10 mL)
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Pseudoephedrine HCl 30 mg
Otc - Purpose
Purpose
Antihistamine
Cough Suppressant
Nasal Decongenstant
Indications & Usage
Uses temporarily relieves these symptoms of the common cold, hay fever or other upper respiratory allergies:
- cough
- runny nose
- nasal congestion
- sneezing
- itching of the nose or throat
- itchy, watery eyes
Warnings
Warnings
Do not use in a child who is takin a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains on MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if child has
- diabetes
- glaucoma
- thyroid disease
- heart diseae
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as chronic bronchitis
- chronic cough that lasts such as occurs with asthma or tranquilizers
- do not use more than directed
- excitability may occur, especially in children
- drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- the child gets nervous, dizzy or sleepless
- cough lasts more than 7 days, comes back or occurs with fever, rash or persistent headache. A persistent cough may be sign of a serious condition.
- Symptoms do not get better within 7 days or occur with fever
When using this product
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
Directions
- dose may be repeated every 6 hours
- do not exceed 4 doses in a 24-hour period
- use enclosed dosage cup only. Do not use any other device.
| Age | Dose |
| Children 6 to 11 years | 2 TSP |
| Children under 6 years | Do not use |
Inactive Ingredient
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C red #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Otc - Questions
Questions or comments? 1-800-645-2158
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