Label: RITE AID DAYTIME SEVERE COLD AND COUGH RELIEF- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder, for solution

  • 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 April 21, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purposes
    Acetaminophen 650 mgPain reliever/fever reducer
    Dextromethorphan hydrobromide 20 mgCough suppressant
    Phenylephrine hydrochloride 10 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • minor sore throat pain
      • headache
      • nasal and sinus congestion
      • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
  • Warnings

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

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

    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

    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

    • in a child under 4 years of age
    • if you are allergic to acetaminophen
    • 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
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    When using this product

    • do not exceed recommended dosage

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain, cough or nasal congestion gets worse or lasts more than 7 days
    • 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 care professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center 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 use more than directed
    • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor
    AgeDose
    children under 4 years of agedo not use
    children 4 to under 12 years of agedo not use unless directed by a doctor
    adults and children 12 years of age and overone packet
    • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
  • Other information

    • each packet contains: potassium 4 mg, sodium 27 mg
    • phenylketonurics: contains phenylalanine 34 mg per packet
    • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
  • Inactive ingredients

    acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

  • Questions or Comments?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE, CAMP HILL, PA 17011

  • PRINCIPAL DISPLAY PANEL - 6 Packet Carton

    RITE
    AID    ®
    PHARMACY

    SEE NEW WARNINGS INFORMATION & DIRECTIONS

    *Compare to the active ingredients in
    Theraflu® Severe Cold & Cough

    daytime
    severe cold
    & cough relief

    acetaminophen 650 mg
    dextromethorphan HBr 20 mg
    phenylephrine HCl 10 mg

    pain reliever/fever reducer
    cough suppressant &
    nasal decongestant

    relieves:
    nasal & sinus congestion
    cough
    body ache
    sore throat pain
    headache
    fever

    berry infused
    with menthol &
    green tea flavors

    6 PACKETS

    PRINCIPAL DISPLAY PANEL - 6 Packet Carton
  • INGREDIENTS AND APPEARANCE
    RITE AID DAYTIME SEVERE COLD AND COUGH RELIEF 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg
    Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide20 mg
    Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride10 mg
    Inactive Ingredients
    Ingredient NameStrength
    acesulfame potassium (UNII: 23OV73Q5G9)  
    aspartame (UNII: Z0H242BBR1)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    anhydrous trisodium citrate (UNII: RS7A450LGA)  
    sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-2112-76 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/28/2013
    Labeler - Rite Aid Corporation (014578892)
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