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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.

Nite Time Cold & Cough

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)Purpose
Diphenhydramine HCl, USP 6.25 mgAntihistamine/Cough suppressant
Phenylephrine HCl, USP 2.5 mgNasal decongestant

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.

Warnings

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.

Ask a pharmacist before use if the child is taking sedatives or tranquilizers.

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.

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 122 TSP
or as directed by a doctor

Keep out of reach of children.

Overdose warning

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.

Other information
  • 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.

Directions
  • 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.

Inactive ingredients

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.

Questions?

877-434-2036

Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ACCUDIAL®
Children's
Nite Time
Cold and Cough

Diphenhydramine
(Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough • Runny Nose
Stuffy Nose • Itchy Throat

Earth-Friendly
Package!

For Ages 6 yrs to under 12 yrs

Tamper Evident

Compares to Children's Triaminic®
Night Time Cold & Cough

GRAPE
FLAVOR

NDC 45014-159-04
4 FL. OZ. (118 mL)

NITE TIME COLD AND COUGH 
diphenhydramine hydrochloride and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-159
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride6.25 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid 
Citric Acid Monohydrate 
Edetate Disodium 
FD&C Blue No. 1 
FD&C Red No. 40 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45014-159-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2013
Labeler - Accudial Pharmaceutical, Inc. (831999201)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546ANALYSIS(45014-159), MANUFACTURE(45014-159), RELABEL(45014-159), REPACK(45014-159)

Revised: 02/2013
 
Accudial Pharmaceutical, Inc.

← See all Nite Time Cold and Cough brands

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.

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