FDA Label for Allergy And Stuffy Nose
View Indications, Usage & Precautions
Allergy And Stuffy Nose Product Label
The following document was submitted to the FDA by the labeler of this product Accudial Pharmaceutical, 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.
Uses
- temporarily relieves
- itchy, watery eyes
- runny nose
- itchy nose or throat
- sneezing
- nasal and sinus congestion as may occur with a cold
Do Not Use
- in a child under 4 years of age
- in a child who is taking 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- for the purpose of making your child sleepy
Ask A Doctor Before Use If The Child Has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as asthma or chronic bronchitis
When Using This Product
- do not exceed recommended dosage
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with a fever. These could be signs of a serious condition.
Directions
- may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
- to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
- specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.
| Age | Dose |
|---|---|
| children under 4 years of age | do not use |
| children 4 to under 6 years of age | do not use unless directed by a doctor |
| children 6 to under 12 years of age | 1-2 tsp. (5-10 mL) |
Other Information
- each teaspoonful contains: sodium 3 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
artificial flavor, benzoic acid, citric acid, disodium EDTA, FD&C yellow #6, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
Questions?
877-434-2036
Principal Display Panel - 118 Ml Carton
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
Allergy
& Stuffy Nose
ACCURATE DOSING
BY WEIGHT
Chlorpheniramine maleate
(Antihistamine)
Phenylephrine HCl
(Nasal Decongestant)
Itchy, Watery Eyes
Runny Nose
Stuffy Nose
Sneezing
For Ages 6 to under 12
Compares to
Children's Triaminic®
Cold & Allergy.
ORANGE
FLAVOR
4 FL. OZ.
(118 mL)
NDC 45014-141-04
* Please review the disclaimer below.