Label: COLD SEVERE CONGESTION- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet 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 August 9, 2022

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

  • Drug Facts

    ​Drug Facts

  • Active ingredients

    Active ingredients (in each tablet)
    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg
    Guaifenesin 200 mg
    Phenylephrine HCI 5 mg

  • Purpose

    Purpose
    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    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

    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

    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.

    Sore throat warning

    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.
    A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

    Do not use

    Do not use
    ■ 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

    Ask a doctor before use if you have
    ■ liver disease

    ■ heart disease
    ■ diabetes

    ■ thyroid disease

    ■ high blood pressure
    ■ 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

    Ask a doctor or pharmacist before use if you are
    ■ taking the blood thinning drug warfarin

    When using this product

    When using this product
    ■ do not exceed recommended dosage

    Stop use and ask a doctor if

    Stop use and ask a doctor if
    ■ pain, nasal congestion or cough gets worse or lasts more than 7 days
    ■ fever gets worse or lasts more than 3 days
    ■ redness or swelling is present
    ■ new symptoms occur
    ■ cough comes back or is accompanied by a fever, rash or persistent headache
    ■ nervousness, dizziness, or sleeplessness occur.
    These could be signs of a serious condition.

    If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Directions

    adults and children

    12 years and over

    ■ take 2 tablets with water every 6-8 hours as needed

    ■ do not take more than 8 tablets in 24 hours, or as directed by a doctor

    children under

    12 years of age

    ask a doctor

  • Other information

    Other information

    ■ store at room temperature 59-86˚ F (15-30˚ C)

  • Inactive ingredients

    Inactive ingredients

    maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid
    *may contain

  • Questions or comments?

    Questions or comments?
    call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • PDP/Package

    Cold

    Acetaminophen, Dextromethorphan HBr,

    Guaifenesin, Phenylephrine HCl

    SEVERE

    CONGESTION

    Non-Drowsy Relief of

    • Cough, Im[pulse to Cough
    • Nasal Congestion
    • Sore Throat
    • 50 PACKETS OF 2 TABLETS

    [barcode]

    3 66715 97187 6

    PDP

    Pouch

  • INGREDIENTS AND APPEARANCE
    COLD SEVERE CONGESTION 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9818
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9818-750 in 1 BOX, UNIT-DOSE09/12/2014
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/12/2014
    Labeler - Lil' Drug Store Products, Inc. (093103646)