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Cold Head Congestion Nighttime

Medically reviewed on March 19, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Cardinal Health
NDC Code: 49781-011

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.

Leader 44-473C-HC

Active ingredients (in each caplet)

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

Purpose

Pain reliever
Antihistamine
Cough suppressant
Nasal decongestant 

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

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

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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
  • marked drowsiness may occur 

Stop use and ask a doctor if
  • cough comes back or occurs with rash or headache that lasts
  • 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

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 (77ºF); 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 

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 49781-011-24

LEADER®

Compare to
Tylenol® Cold Head
Congestion Nighttime
active ingredients*

Cold
Head Congestion

Nighttime
Contains 4 Medicines:

Pain Reliever - Acetaminophen
Nasal Decongestant • Phenylephrine HCl
Cough Suppressant • Dextromethorphan HBr
Antihistamine • Chlorpheniramine Maleate
• Headache/Sore Throat
• Runny Nose • Coughing

• Nasal Congestion

with Cool Blast Flavor

SATISFACTION
GUARANTEED

24 COOL CAPLETS

Actual Size

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Head Congestion Nighttime.
50844    ORG011347308

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

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 4829842
www.myleader.com 1-800-200-6313

All LEADER® Brand products are
100% satisfaction guaranteed or return
to place of purchase for a full refund.

Leader 44-473C

COLD HEAD CONGESTION  NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-011
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
FD&C BLUE NO. 1 
CELLULOSE, MICROCRYSTALLINE 
TALC 
SUCRALOSE 
STARCH, CORN 
MAGNESIUM STEARATE 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code44;473
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-011-242 BLISTER PACK in 1 CARTON
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
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(49781-011)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(49781-011)

 
Cardinal Health

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Further information

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

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