HEALTH MART MULTI-SYMPTOM COLD AND FLU NIGHT TIME - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled 
McKesson

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.

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Active Ingredients (in each softgel)

Acetaminophen 325mg

Dextromethorphan Hydrobromide 15mg

Doxylamine Succinate 6.25 mg

Purpose

Pain reliever/ fever reducer

Cough suppressant

Antihistimine

Uses

temporarily relieves common cold/flu symptoms

  • cough due to minor throat and bronchial irritation
  • sore throat pain
  • headache
  • minor aches/pains
  • fever
  • runny nose and sneezing


Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maxiumum daily amount.
  • with other drugs containing acetaminophen,
  • 3 or more alcoholic drinks everyday while using this product.
Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by or followed by fever, headache rash, nausea or vomiting, consult a doctor promptly.

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Do not use

with any other drug containing acetaminophen (prescription or non-prescription). 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 stoppig the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor of pharmacist before taking this product.

Ask a doctor before using if you have

  • liver disease
  • heart disease
  • asthma
  • emphysema
  • thyroid disease
  • diabetes
  • glaucoma
  • high blood pressure
  • cough with excessive phlegm (mucus)
  • breathing problems
  • chronic bronchitis
  • persistent or chronic cough
  • cough associated with smoking
  • difficulty in urinating due to an enlarged prostate gland

Ask a doctor of pharmacist before use if you are

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

When using this product

  • do not exceed the recommended dosage
  • do not use with other products containing acetaminophen
  • do not use for more than 7 days
  • excitability may occur especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives,a nd tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • swelling or redness is present
  • symptoms do not get better or are accompanied by a fever that lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

  • Take only as recommended - See overdose warning
  • Do not exceed 4 doses per 24 hours
adults and children 12 years of age and older      swallow 2 softgels with water every 6 hours
children 4 to 12 years of age                                    ask a doctor
children under 4 years of age                                   do not use

If taking NiteTime and DayTime softgels carefully read each label to insure correct dosing.

Other Information

store at room temperature 15-30 degrees C (59-86F) and avoid excessive heat.

This product does not contain phenylpropanolamine (PPAP

*This product is not manufactured or distributed by Procter and Gamble, owner of the registered trademear Vicks (r) NyQuil(r)


Distributed by:
PL Developments
Westbury, NY 11590 USA


Questions or Comments?
Call toll free 1-800-753-3935



Keep outer carton for complete warnings and product information.


THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

*Compare to the active ingredients in Vicks Nyquil

NDC 59726-480-10

SEE NEW WARNINGS INFORMATION

 Multi-symptom

NiteTime Liquid Capsules

Cold/Flue Relief

Pain reliever, fever reducer, cough suppressant, antihistimine

PARENTS: learn about teen medicine abuse www.stopmedicineabuse.org



ACETAMINOPHEN
Dextromethorphan HBr, Doxylamine Succinate

10 SOFTGELS

Inactive Ingredients

DandC Yellow #10, FDandC Blue#1, gelatin, glycerin, polyethylene glycol 400 NF, povidone, propylene glycol USP, purified water USP, sorbitan, sorbitol, and white edible ink. May also contain: polyethylene glycol (PEG) -600

Product Outer Packaging

NiteTime Liquid Capsules

HEALTH MART MULTI-SYMPTOM COLD AND FLU NIGHT TIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0084
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
Colorgreen (GREEN) Scoreno score
ShapeOVAL (OVAL) Size10mm
FlavorImprint Code P30;94A
Contains    
Packaging
#Item CodePackage Description
1NDC:62011-0084-11 in 1 BOX
112 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/09/2012
Labeler - McKesson (177667227)

Revised: 04/2012
 
McKesson