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Cold Formula Daytime Nighttime, Non-Aspirin, Multi-Symptom

Medically reviewed on June 18, 2018

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0529

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.

Assured 44-470C473

Active ingredients
(in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant 

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
  • helps clear nasal passages 
  • promotes nasal and sinus drainage
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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. 

Ask a doctor before use if you have
  • liver disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • heart disease
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that lasts
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. 

Keep out of reach of children.

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Directions
  • do not take more than directed 
    (see overdose warning)
  • adults and children 12 years and over:
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • store at 25ºC (77ºC); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide 

Questions or comments?

1-800-426-9391 

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
    • sneezing and runny nose
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • 3 or more alcoholic drinks every day while using this product
  • with other drugs containing acetaminophen

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.

Ask a doctor before use if you have
  • liver disease
  • diabetes
  • glaucoma
  • heart disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • high blood pressure
  • thyroid disease
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin 
  • taking sedatives or tranquilizers 

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

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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed
    (see overdose warning)
  • adults and children 12 years and over:
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • store at 25ºC (77ºC); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide 

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENTS OF TYLENOL® COLD MULTI-SYMPTOM*

NON-ASPIRIN
MULTI-SYMPTOM
COLD FORMULA

DAYTIME NON-DROWSY

• Acetaminophen
  Pain Reliever / Fever Reducer  
• Dextromethorphan HBr
  Cough Suppressant
• Phenylephrine HCl
  Nasal Decongestant

 

 

 12 caplets

With Cool Blast Flavor

Actual Size

NIGHTTIME

Acetaminophen
  Pain Reliever / Fever Reducer
• Chlorpheniramine Maleate
   Antihistamine†
• Dextromethorphan HBr
  Cough Suppressant
• Phenylephrine HCl
  Nasal Decongestant

 

 12 caplets

With Cool Blast Flavor

Actual Size

Fever, Headache, Sore Throat, Coughing, Nasal Congestion & Runny Nose†
†Antihistamine in Nighttime only
PSEUDOEPHEDRINE FREE

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Daytime and Nighttime.
50844        ORG0213.470/0113.47308

Assured 44-470C473



COLD FORMULA  DAYTIME NIGHTTIME, NON-ASPIRIN, MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0529
Packaging
#Item CodePackage Description
1NDC:33992-0529-81 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
COLD FORMULA  DAYTIME, MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
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
POLYETHYLENE GLYCOLS 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorMENTHOLImprint Code44;470
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/15/2005
Part 2 of 2
COLD FORMULA  NIGHTTIME, MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
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
POLYETHYLENE GLYCOLS 
STARCH, CORN 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
CROSPOVIDONE 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize17mm
FlavorMENTHOLImprint Code44;473
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/21/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/21/2005
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(33992-0529)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0529)

 
GREENBRIER INTERNATIONAL, INC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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