Skip to Content

← See all NITETIME COUGH brands

NITETIME COUGH by KINGSTON PHARMA LLC

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: KINGSTON PHARMA LLC
NDC Code: 71027-041

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.

NITETIME COUGH

Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg

Purpose:
Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

  • Temporarily relieves these common cold/flu symptoms
    1. Cough due to minor throat and bronchial irritation
    2. Runny nose and sneezing
    3. Minor aches and pains
    4. Headache
    5. Sore throat
    6. Fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • More than 4 doses in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use:

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • To make a child sleep.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

Ask a doctor before use if you have

  • Glaucoma
  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Cough that occurs with too much phlegm (mucus)
  • A sodium restricted diet

Ask a doctor or pharmacist before use if you are

  • Taking sedatives or tranquilizers
  • Taking the blood thinning drug warfarin

When using this product

  • Do not exceed recommended dosage
  • Excitability may occur especially in children
  • Marked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

  • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.

If pregnant or breast-feeding, ask a health professional before use.

Directions:

  • Do not take more than directed.
  • Use enclosed dosing cup.
  • Do not take more than 4 doses in 24-hours.
  • Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 6 hours.
  • Children 4 to under 12 years: ask a doctor
  • Children under 4 years: do not use
  • When using other Daytime or Nite time products, carefully read each label to insure correct dosing

Other information

  • Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
  • Each tablespoon contains: Sodium 46mg

Inactive ingredients: Alcohol, Anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sodium citrate and Purified Water.

(packs: 4oz, 6oz, 10oz & 12oz) Kingston NDC# 71027-041-06

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662

NITETIME COUGH 
nitetime cough liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71027-041
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
METHYL SALICYLATE 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
SODIUM CITRATE, UNSPECIFIED FORM 
WATER 
Packaging
#Item CodePackage Description
1NDC:71027-041-061 BOTTLE in 1 CARTON
1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2017
Labeler - KINGSTON PHARMA LLC (080386521)
Registrant - KINGSTON PHARMA LLC (080386521)
Establishment
NameAddressID/FEIOperations
KINGSTON PHARMA LLC080386521manufacture(71027-041)

Revised: 03/2017
 
KINGSTON PHARMA LLC

← See all NITETIME 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.

Hide