Label: ARAMARK MULTI-SYMPTOM COLD RELIEF- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr 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 June 3, 2021

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

  • Drug Facts

    Cold Relief Tablets
    Active Ingredients (in each tablet)
    Acetaminophen 325 mg
    Guaifenesein 200 mg
    Phenylephrine HCl 5 mg
    Dextromethorphan HBr 15 mg

  • PURPOSE

    Purpose
    Acetaminophen.....................Pain Reliever/Fever Reducer
    Guaifenesein ........................Expectorant
    Phenylephrine HCl ...............Decongestant
    Dextromethorphan HBr. .......Antitussive

  • INDICATIONS & USAGE

    Uses: temporarily:
    • relieves nasal congestion associated with sinusitis
    • relieves nasal confestion due to the common cold, hay
      fever or other respiratory allergies
    • relieves sinus congestion and pressure, helps
      decongest sinus openings and passages
    • restores free breathing
    • helps loosen phlegm (mucus) and thin bronchial
      secretions to rid the bronchial passages of
      bothersome mucus, drain bronchial tubes, and make
      coughs more productive
    • temporarily suppresses cough due to minor throat
      and bronchial irritation associated with a cold or
      inhaled irritants
    Temporarily relieves minor aches, pains and fever
    associated with: • headache • backache • common
    cold • muscular aches • toothache • menstrual cramps
    o make coughs more productive

  • WARNINGS

    Warnings:
    Liver Warning: This product containsacetaminophen.
    Severe liver damage may occur if you take:
    • more than 8 tablets in 24 hours
    • with other drugs containing acetaminophen
      (prescription or nonprescription)
    • Ask a doctor or pharmacist before using with other
      drugs if you are not sure
    • 3 or more alcoholic drinks every day while using
      this product.

  • DO NOT USE

    Do not:
    • use with any other product containing
      acetaminophen. This will provide more than the
      recommended dose (overdose) of acetaminophen
      and could cause serious health concerns.
    • use more than the recommended dose
    • for more than 10 days for pain unless directed by
      a doctor
    • for more than 3 days for fever unless directed by a
      doctor
    • when using this product do not exceed
      recommended dose 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 MAOI drug. If you do not
      know if your prescription drug contains an MAOI,
      consult a doctor or pharmacist before taking this
      product

  • STOP USE

    Stop use and ask a doctor if:

    • symptoms do not improve
    • pain or fever persists or gets worse
    • new symptoms occur
    • redness or swelling is present
    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or are
      accompanied by a fever
    • cough persists for more than 1 week, tends
      to recur, or is
    • accompanied by a fever, rash, or persistant headache.
    • A persistant cough may be a sign of a serious
      condition

  • ASK DOCTOR

    Ask a doctor before use if you have:
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the
      prostate gland
    • persistent or chronic cough such as occurs with
      smoking,
    • asthma, chronic bronchitis, or emphysema or where
      cough is
    • accompanied by excessive phlegm (mucus)

  • PREGNANCY

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of accidental 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.

  • DOSAGE & ADMINISTRATION

     Directions:
    • Adults and children 12
      years of age and older:
    Take 2 tablets every 6 to
    8 hours as needed. Do
    not exceed 8 tablets in 24
    hours, or as directed by a
    doctor.
    • Children under 12 years:Consult a doctor.

  • OTHER SAFETY INFORMATION

    Other Information:
    Tamper evident. Do not use if packet is torn, cut or
    opened Store at controlled room temperature 15° to
    30°C (59° to 86° F) Avoid excessive heat and humidity

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Maltodextrin, Microcrystalline Cellulose, Povidone,
    Sodium Starch Glycolate, Starch, Stearic Acid

  • Product Labeling

    aramark

    100 TABLETS            
    PER BOX         Part # 82233B

    Multi-Symptom
    COLD RELIEF

    Non-Pseudo Tablet
    Decongestant

    Temporary relief of minor
    aches, pains, headache,
    muscular aches, fever and
    nasal congestion associated
    with the common cold.

    Compare active ingredient to:
    DRISTAN Cold and Sinus®
    Registered Trademark of Pfizer

    Retain carton for complete product information

    MANUFACTURED FOR:

    Aramark
    Lenexa, KS 66219
    866-362-2691

    aramarkuniform.com

    100 Tablet Box

    0107-100ct tab Box

    250 Tablet Box

    0107-2 250ct tab Box

    2-Tablet Packet

    0107 2-tab packet

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK MULTI-SYMPTOM COLD RELIEF 
    acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-0107
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-0107-150 in 1 BOX05/14/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:81238-0107-2125 in 1 BOX05/14/2021
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/14/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(81238-0107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation944090448manufacture(81238-0107)