Label: MULTI-SYMPTOM COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated

  • NDC Code(s): 63941-473-08
  • Packager: Valu Merchandisers Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 14, 2021

If you are a consumer or patient please visit this version.

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

    Liver warning: This product contains acetaminophen. 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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    If a skin reaction occurs, stop use and seek medical help right away.

    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

    • 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.
    • 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 have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland
    • liver disease
    • heart disease
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • diabetes
    • a breathing problem such as emphysema or chronic bronchitis
    • high blood pressure
    • glaucoma
    • thyroid disease

    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
    • marked drowsiness may occur
    • excitability may occur, especially in children
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages

    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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
    • 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
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • 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, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Best
    Choice®

    NIGHTTIME
    Multi-Symptom Cold

    Actual Size

    ACETAMINOPHEN - Pain Reliever/Fever Reducer
    Chlorpheniramine maleate - Antihistamine
    Dextromethorphan HBr - Cough Suppressant
    Phenylephrine HCl - Nasal Decongestant

    Relieves Fever/Headache,
    Sore Throat, Runny Nose,
    Coughing, Nasal Congestion
    Pseudoephedrine Free

    24 Cool Caplets
    with Cool Blast Flavor

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

    50844        REV0718E47308

    PROUDLY DISTRIBUTED BY:
    VALU MERCHANDISERS, CO.
    5000 KANSAS AVE
    KANSAS CITY, KS 66106

    Best Choice®
    100% Guaranteed
    www.bestchoicebrand.com

    Best Choice 44-473C

    Best Choice 44-473C

  • INGREDIENTS AND APPEARANCE
    MULTI-SYMPTOM COLD 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-473
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 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
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize17mm
    FlavorMINT (Cool Blast) Imprint Code 44;473
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-473-082 in 1 CARTON07/21/2005
    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 finalpart34107/21/2005
    Labeler - Valu Merchandisers Company (868703513)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(63941-473)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(63941-473)