FDA Label for Nite Time Cold And Cough
View Indications, Usage & Precautions
Nite Time Cold 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
- sneezing
- itchy nose or throat
- runny nose
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold
Do Not Use
- in a child under 6 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.
- with any other product containing diphenhydramine, even one used on skin
- 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
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
- a breathing problem such as 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
- cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. 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.
| children under 6 years of age | do not use |
| children 6 to under 12 years of age | 1-2 tsp. (5-10 mL) |
Other Information
- each teaspoonful contains: sodium 4 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
artificial flavor, benzoic acid, citric acid, disodium edetate, FD&C blue no. 1, FD&C red no. 40, 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
Nite Time
Cold & Cough
ACCURATE DOSING
BY WEIGHT
Diphenhydramine HCl
(Antihistamine/Cough Suppressant
Phenylephrine HCl
(Nasal Decongestant)
Cough Relief
Runny, Stuffy Nose
Itchy Throat
For Ages 6 to under 12
Compares to Children's
Triaminic® Night Time
Cold & Cough.
GRAPE
FLAVOR
4 FL. OZ.
(118 mL)
NDC 45014-154-04
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