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

  • NDC Code(s): 37808-768-20
  • Packager: H. E. Butt Grocery Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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 non-steroidal 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 non-prescription 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

    ■ 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

    Ask a doctor before us if 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

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

  • 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 a 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

    ■ 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 breastfeeding,

    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.

  • OVERDOSAGE

    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, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

  • Questions or comments?

    Call (1-888-228-6937)

  • Package Label.Principle Display Panel

    HEB Cold Orange 20ct

  • INGREDIENTS AND APPEARANCE
    EFFERVESCENT ORANGE COLD RELIEF 
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-768
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-768-2010 in 1 CARTON01/30/2018
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/30/2018
    Labeler - H. E. Butt Grocery Company (007924756)