Label: EFFERVESCENT COLD RELIEF- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

  • NDC Code(s): 69842-768-20, 69842-768-36
  • Packager: CVS Pharmacy
  • 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 April 22, 2021

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

  • Active ingredients

    Aspirin 325 mg (NSAID)*

    Chlorpheniramine maleate 2 mg

    Phenylephrine bitartrate 7.8 mg

    *Nonsteroidal anti-inflammatory drug

  • Purpose

    Aspirin 325 mg (NSAID)*..........................Pain reliever/fever reducer

    Chlorpheniramine maleate 2 mg...............Antihistamine

    Phenylephrine bitartrate 7.8 mg................Nasal decongestant

    *Nonsteroidal anti-inflammatory drug

  • Uses

    ■ temporarily relieves these symptoms of the common cold:

    ■ fever ■ sneezing ■ nasal congestion

    ■ sore throat ■ headache

    ■ minor aches and pains ■ runny nose

    ■ sinus congestion and pressure

  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

    ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed

    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 have ever had an allergic reaction to any other pain reliever/fever reducer

    ■ if you are allergic to aspirin

    ■ 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

    Ask a doctor before use if ■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you are taking sedatives or tranquilizers. You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet

  • Ask a doctor or pharmacist before use if you are

    Ask a doctor or pharmacist before use if you are ■ presently taking a prescription drug

    ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

  • When using this product

    When using this product do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by doctor.

    ■ do not use more than directed

    ■ you may get drowsy

    ■ avoid alcoholic drinks

    ■ excitability may occur, especially in children

    ■ alcohol, sedatives and tranquilizers may increase drowsiness

    ■ be careful when driving a motor vehicle or operating machinery

  • Stop use and ask a doctor if

    Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ an allergic reaction occurs. Seek medical help right away.

    ■ pain or nasal congestion gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days

    ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or a loss of hearing occurs ■ nervousness, dizziness or sleeplessness occurs

  • If pregnant or breast-feeding,

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • Keep out of reach of children

    Keep out of reach of children.

  • In case of overdose,

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ do not use more than directed (see overdose warning)

    ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours

    ■ do not take more than 8 tablets in 24 hours

    children under 12 years: ask a doctor

  • Other information

    each tablet contains:
    sodium 464 mg

    ■ phenylketonurics: contains phenylalanine 9 mg per tablet

    ■ store at room temperature (59°-86°F)

  • Inactive Ingredients

    acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

  • Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    CVS.com

    1-800-SHOP CVS

  • Package Label.Principle Display Panel

    CVS Health Cold 36ct

  • INGREDIENTS AND APPEARANCE
    EFFERVESCENT COLD RELIEF 
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-768
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MANNITOL (UNII: 3OWL53L36A)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    POVIDONE K30 (UNII: U725QWY32X)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASPARTAME (UNII: Z0H242BBR1)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-768-2020 in 1 CARTON10/29/201505/31/2020
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69842-768-3618 in 1 CARTON03/10/2017
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/29/2015
    Labeler - CVS Pharmacy (062312574)