Label: COMTREX COUGH AND COLD DAY/NIGHT- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate kit

  • NDC Code(s): 55741-524-24
  • Packager: Dr. Reddy's Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL

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 Label Information

Updated June 15, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)
    (Cold Multi-Symptom Day)
    Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
    Active ingredients (in each caplet)
    (Cold Multi-Symptom Night)
    Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Chlorpheniramine maleate 2 mgAntihistamine
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

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

    • diabetes
    • high blood pressure
    • heart disease
    • thyroid disease
    • liver disease
    • 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)
    • glaucoma (Cold Night only)
    • a breathing problem such as emphysema or chronic bronchitis (Cold Night only)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Cold Night only)

    When using this product

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

    Stop use and ask a doctor if

    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
    • 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • see end flap for expiration date and lot number
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients (Cold Day)

    corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, sucralose, titanium dioxide, triacetin

  • Inactive ingredients (Cold Night)

    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?

    1-800-790-6417

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC 55741-524-24

    COMTREX®
    COLD & COUGH

    DAY

    Acetaminophen

    Pain Reliever
    Fever Reducer

    Dextromethorphan HBr

    Cough Suppressant

    Phenylephrine HCl

    Nasal Decongestant

    12 COATED CAPLETS

    NIGHT

    Acetaminophen

    Pain Reliever
    Fever Reducer

    Chlorpheniramine maleate

    Antihistamine

    Dextromethorphan HBr

    Cough Suppressant

    Phenylephrine HCl

    Nasal Decongestant

    12 COATED CAPLETS

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    COMTREX COUGH AND COLD   DAY/NIGHT
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-524
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-524-241 in 1 CARTON; Type 0: Not a Combination Product05/24/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK 12 
    Part 1 of 2
    COMTREX COLD MULTI-SYMPTOM DAY CAPLET 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    starch, corn (UNII: O8232NY3SJ)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (UNII: 68401960MK)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    aluminum oxide (UNII: LMI26O6933)  
    hypromelloses (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    polydextrose (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sucralose (UNII: 96K6UQ3ZD4)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVAL (oblong) Size16mm
    FlavorImprint Code Cx
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/24/2015
    Part 2 of 2
    COMTREX COLD MULTI-SYMPTOM NIGHT CAPLET 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate2 mg
    Inactive Ingredients
    Ingredient NameStrength
    starch, corn (UNII: O8232NY3SJ)  
    crospovidone (UNII: 68401960MK)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C blue no. 2 (UNII: L06K8R7DQK)  
    aluminum oxide (UNII: LMI26O6933)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    polyvinyl alcohol (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium starch glycolate Type A corn (UNII: AG9B65PV6B)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sucralose (UNII: 96K6UQ3ZD4)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVAL (oblong) Size16mm
    FlavorImprint Code Cx
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/24/2016
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)