DAY TIME COLD MULTI-SYMPTOM COOL BLAST (TYLENOL MULTI SYMPTOM COOL BLAST DAYTIME) LIQUID [P & L DEVELOPMENT, LLC]

DAY TIME COLD MULTI-SYMPTOM COOL BLAST (TYLENOL MULTI SYMPTOM COOL BLAST DAYTIME) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0192-8
Set ID 7d7cbf19-6533-4788-8dc8-e8bb9d116447
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active Ingredients

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

  • Purposes

    Acetaminophen...........................Pain reliever/fever reducer
    Guaifenesin..........Chest Congestion
    Dextromethorphan HBr..............Cough suppressant
    Phenylephrine HCI......................Nasal decongestant

  • Uses

    • temporarily relieves the following cold/flu
    symptoms: • minor aches and pains • cough
    • headache • temporarily reduces fever • congestion •stuffy nose

  • Warnings

    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if your child takes:
    • more than 5 doses in 24 hours, which is the
    maximum daily amount
    • with other drugs containing acetaminophen

  • Do Not Use

    • to make a child sleepy
    • in a child who is 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 child's
    prescription drug contains an MAOI, ask a doctor
    or pharmacist before giving this product.
    • with any other drug containing acetaminophen
    (prescription or non-prescription). If you are not
    sure whether a drug contains acetaminophen,
    ask a doctor or pharmacist.

  • Ask a doctor before use if the child has

    • a breathing problem such as chronic bronchitis
    • persistent or chronic cough such as occurs with
    asthma • cough that occurs with too much phlegm
    (mucus) • heart disease • high blood pressure
    • thyroid disease • diabetes • glaucoma • liver disease

  • Ask a doctor or pharmacist before use if the child is taking

    • sedatives or tranquilizers
    • the blood thinning drug warfarin

  • When using this product

    • do not exceed recommended dosage (see overdose warning)
    • may cause excitability, especially in children
    • marked drowsiness may occur • sedatives and
    tranquilizers may increase drowsiness

  • Stop use and ask a doctor if

    • new symptoms occur
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • pain, nasal congestion or cough gets worse or
    lasts for more than 5 days
    • nervousness, dizziness or sleeplessness occur
    • cough comes back or occurs with rash or headache
    that lasts. These could be signs of a serious
    condition

  • Keep this and all drugs out of the reach of children.

    Overdose Warning: Taking more than the
    recommended dose (overdose) could cause serious
    health problems, including liver damage. In case of
    accidental overdose, seek professional assistance or
    contact a Poison Control Center immediately. Quick
    medical attention is critical even if you do not notice
    any signs or symptoms.

  • Directions

    • do not exceed recommended dosage
    (see overdose warning) Use the dosage cup provided

    Age (yr)                                                                                            Dose (tsp or mL)
    children under the age of 12; this will provide more                              do not usethis product on children under 12 years of age

    than the recommended dose (overdose) and may

    cause liver damage                                 

    Adults and children 12 years of age and older:                                     Take 2 tbsp (30mL) in dosage cup provided every 4 hours

                                                                                                            Do not take more than 12 tbsp (180mL) in 24 hours

  • Other Information

    • store at controlled room temperature

  • Inactive Ingredients

    blue 1, citric acid, flavors, glycerin, purified water, 
    sodium benzoate, sorbitol, sucralose, sorbitol, propylene glycol

  • Principal Display Panel

    Cold Multi-Symptom Cool Blast

    Daytime

    Acetaminophen Fever and sore throat

    Dextromethorphan HBr Cough

    Guaifenesin Chest congestion

    Phenylephrine HCI stuffy nose

    For ages 12 and over

    alcohol .5 percent

    Compare to active ingredient in Tylenol Cold multi-symptom daytime

    Manufactured by Aaron Industries, Inc PO box 801 Lynwood CA 90262

    8 fl oz 237mL

    image of label
  • INGREDIENTS AND APPEARANCE
    DAY TIME COLD MULTI-SYMPTOM COOL BLAST 
    tylenol multi symptom cool blast daytime liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0192
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Mint Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0192-8237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201012/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/01/201012/30/2021
    Labeler - P & L Development, LLC (101896231)

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