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Multi Sympton Cold Day Night

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0156

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.

Drug Facts

Active ingredients for Night(in each tablet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Active ingredients for Day(in each tablet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Purpose for Night

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Purpose for Day

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses
  • temporarily relieves these common cold symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sneezing and runny nose (Night only)
  • sinus congestion and pressure (Day only)
  • helps clear nasal passages
  • relieves cough to help you sleep (Night only)
  • promotes nasal and sinus drainage (Day only)
  • temporarily reduces fever

Warnings

Alcohol warning:If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.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 product containing acetaminophen
  • 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 you prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • 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 breathing problem such as emphysema or chronic bronchitis (Night only)
  • glaucoma (Night only)

Ask a doctor or pharmacist before use if you are (Night only)

taking sedatives or tranquilizers (Night only)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Night only)
  • marked drowsiness may occur (Night only)
  • alcohol, sedatives and tranquilizers may increase drowsiness (Night only)
  • avoid alcoholic drinks (Night only)
  • be careful when driving a motor vehicle or operating machinery (Night only)

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

Enter section text here

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Directions
  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 tablets every 4 hours
  • swallow whole - do not crush, chew or dissolve
  • do not take more than 12 tablets in 24 hours
children under 12 years
Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage


Other information
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive ingredients

microcrystalline cellulose, lactose, hydroxypropyl cellulose, sodium starch glycolate, sillicon dioxide, magnesium stearate, hypromellose (Night only), bleu no.1 (Night only), titanium dioxide (Night only), polyethylene glycol (Night only), anhydrous citric acid, sodium citrate, ethanol, FDC Yellow no.5 (Day only),

Package label

MULTI SYMPTON COLD DAY NIGHT 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0156
Packaging
#Item CodePackage Description
1NDC:67510-0156-21 KIT (KIT) in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
MULTI SYMPTOM NIGHT 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet
Product Information
Item Code (Source)NDC:67510-1156
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
HYDROXYPROPYL CELLULOSE 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
SODIUM CITRATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
Colorblue (light blue) Scoreno score
ShapeROUNDSize9mm
FlavorImprint CodeMS
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-1156-11 BLISTER PACK (BLISTER PACK) in 1 BOX
112 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Part 2 of 2
MULTI SYMPTON DAY NON DROWSY 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet
Product Information
Item Code (Source)NDC:67510-2156
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
HYDROXYPROPYL CELLULOSE 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
SODIUM CITRATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUNDSize9mm
FlavorImprint CodeMS
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-2156-11 BLISTER PACK (BLISTER PACK) in 1 BOX
112 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
MULTI SYMPTON COLD DAY NIGHT 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-9156
Packaging
#Item CodePackage Description
1NDC:67510-9156-01 KIT (KIT) in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 10 
Part 21 BLISTER PACK 10 
Part 1 of 2
MULTI SYMPTOM NIGHT 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet
Product Information
Item Code (Source)NDC:67510-3156
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
HYDROXYPROPYL CELLULOSE 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
SODIUM CITRATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
Colorblue (light blue) Scoreno score
ShapeROUNDSize9mm
FlavorImprint CodeMS
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-3156-11 BLISTER PACK (BLISTER PACK) in 1 BOX
110 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Part 2 of 2
MULTI SYMPTON DAY NON DROWSY 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet
Product Information
Item Code (Source)NDC:67510-4156
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
HYDROXYPROPYL CELLULOSE 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
SODIUM CITRATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUNDSize9mm
FlavorImprint CodeMS
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-4156-11 BLISTER PACK (BLISTER PACK) in 1 BOX
110 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Labeler - Kareway Product, Inc. (121840057)

Revised: 02/2013
 
Kareway Product, Inc.

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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