FDA Label for Cough And Cold
View Indications, Usage & Precautions
Cough And Cold 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 as may occur with a cold
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
When Using This Product
- do not use more than directed
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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 |
|---|---|
| under 6 years | do not use |
| 6 to under 12 years | 1-2 tsp. (5-10 mL) every 6 hours |
Other Information
- each teaspoon contains: sodium 2 mg
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.
Questions?
877-434-2036
Principal Display Panel - 118 Ml Carton
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
Cough & Cold
Long-Acting
ACCURATE DOSING
BY WEIGHT
Chlorpheniramine Maleate
(Antihistamine)
Dextromethorphan HBr
(Cough Suppressant)
RELIEVES
Cough: Up to 8 Hours
Runny Nose
For Ages 6 to under 12
Compares to Children's
Robitussin® Cough &
Cold Long-Acting.
FRUIT
PUNCH
FLAVOR
4 FL. OZ.
(118 mL)
NDC 45014-151-04
* Please review the disclaimer below.