Nite Time Cold and Cough by Accudial Pharmaceutical, Inc.
Dosage form: solution
Ingredients: Diphenhydramine Hydrochloride 6.25mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-159
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredient (in each 5 mL = 1 teaspoon)||Purpose|
|Diphenhydramine HCl, USP 6.25 mg||Antihistamine/Cough suppressant|
|Phenylephrine HCl, USP 2.5 mg||Nasal decongestant|
- 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
- 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.
Ask a pharmacist before use if the child is taking sedatives or tranquilizers.
- 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.
Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.
|Age (yr)||Dose (TSP)|
|TSP = teaspoon|
|under 6 yrs.||ask a doctor|
|6 to under 12||2 TSP|
|or as directed by a doctor|
Keep out of reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.
- each teaspoon contains: sodium 9 mg
- store between 20°-25°C (68°-77°F)
- tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
- may be given every 4 hours
- do not use more than 6 times in 24 hours
- use only enclosed dosing cup to dose this product. Do not use any other dosing device.
artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C blue #1, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408
Cold and Cough
Phenylephrine HCl (Nasal Decongestant)
Relieves Cough • Runny Nose
Stuffy Nose • Itchy Throat
For Ages 6 yrs to under 12 yrs
Compares to Children's Triaminic®
Night Time Cold & Cough
4 FL. OZ. (118 mL)
|NITE TIME COLD AND COUGH
diphenhydramine hydrochloride and phenylephrine hydrochloride solution
|Labeler - Accudial Pharmaceutical, Inc. (831999201)|
|Bio-Pharm, Inc.||801652546||ANALYSIS(45014-159), MANUFACTURE(45014-159), RELABEL(45014-159), REPACK(45014-159)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.