Label: COLD MULTI-SYMPTOM DAY-TIME- acetaminophen,guaifenesin, dextromethorphan hbr and phenylephrine hci tablet

  • 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 December 23, 2014

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  • Active ingredient

    Acetaminophen 325 mg
    Guaifenesin 200 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCI 5 mg

  • Purpose

    Analgesic/Antipyretic
    Expectorant
    Cough suppressant
    Decongestant

  • Uses

    for the temporary relief of the following cold/flu symptoms: •minor aches and pains • headache • sore throat •nasal congestion •cough •impulse to cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets in 24 hours, which is the maximum daily amount 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 products containing acetaminophen (prescription or nonprescription). If you are not
    sure whether a drug contains acetaminophen, ask a doctor or pharmacistif 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 drugs. 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) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

    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 use exceed recommended dosage

    Stop use and ask a doctor if

    ■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion or cough gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ 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 overdose, contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

  • Directions

    Adults and children 12 years and over: take 2 caplets every 4 hours ■ do not take more than a total of 12 caplets in 24 hours
    Children under 12 years: Do not use this adult product in children under 12 years of age. This will provide more than recommended dose (overdose) and may cause liver damage

  • Other Information

    store at room temperature 59°-86° F (15°-30° C) do not use if blister is torn or open

  • Inactive Ingredients

    corn starch, croscarmellose sodium, crospovidone, FD&C Yellow #10, hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

  • Questions or comments?

    Call toll free 1-888-952-0050

  • Package/Label Principal Display Panel

    Z:\SPL-OTC Mono\Allegiant Health\Cold Multi Symptom Daytime\LB0887.jpg
  • INGREDIENTS AND APPEARANCE
    COLD MULTI-SYMPTOM  DAY-TIME
    acetaminophen,guaifenesin, dextromethorphan hbr and phenylephrine hci tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-323
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code AZ323
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-323-8612 in 1 BLISTER PACK; Type 0: Not a Combination Product12/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/23/2014
    Labeler - Allegiant Health (079501930)
    Registrant - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930ANALYSIS(69168-323) , LABEL(69168-323) , MANUFACTURE(69168-323) , PACK(69168-323) , RELABEL(69168-323) , REPACK(69168-323)
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