FDA Label for Runny Nose And Cough
View Indications, Usage & Precautions
Runny Nose And Cough 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 cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily restores freer breathing through the nose
Do Not Use
- to sedate a child or to make a child sleepy
- if you are now 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If The Child Has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
When Using This Product
- do not use more than directed
- may cause marked drowsiness
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
- you get nervous, dizzy, or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Directions
- do not take more than 4 doses in any 24-hour period
- 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 6 to under 12 years | 1½-3 tsp. (7.5-15 mL) every 6 hours |
| children under 6 years | do not use |
Other Information
- each teaspoon contains: sodium 3 mg
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.
Questions?
877-434-2036
Principal Display Panel - 118 Ml Carton
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
ACCURATE DOSING
BY WEIGHT
Nasal Decongestant
Antihistamine
Cough Suppressant
RELIEVES
Nasal Congestion
Runny Nose
Itchy, Watery Eyes
Coughing, Sneezing
For Ages 6 to under 12
Alcohol Free
Compares to the
active ingredients in
Children's Dimetapp®
Cold & Cough.
GRAPE
FLAVOR
4 FL. OZ.
(118 mL)
NDC 45014-153-04
Runny Nose & Cough
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