Cold multi symptom solution

Active ingredients (in each 15 ml = 1 tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • runny nose and sneezing
  • cough
  • sinus congestion and pressure
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever

Warnings

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: 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: 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 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 Parkinsons 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

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 exceed recommended dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • 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 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.

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

Directions

  • do not take more than directed (see overdose warning)
  • mL = milliliter; TBSP = tablespoon
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
take 30 mL (2 TBSP) in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL (10 TBSP) in 24 hours, unless directed by a doctor

    adults and children 12 years and over

    children under 12 years

    ask a doctor

    Other information

    • each 15 mL (1 TBSP) contains: sodium 5 mg
    • store at 20-25C (68-77F). Do not refrigerate.

    Inactive ingredients

    anhydrous citric acid, FD&C blue no. 1, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

    Questions or comments?

    1-800-719-9260

    Ingredients and appearance - Product information

    Cold multi symptom solution- Acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37808-920
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 15 mL
    Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 15 mL
    Doxylamine succinate ( UNII: V9BI9B5YI2)( Doxylamine - UNII: 95QB77JKPL ) 6.25 mgin 15 mL
    Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 15 mL

    Inactive Ingredients

    Ingredient Name Code
    Anhydrous citric acid ( UNII: XF417D3PSL)
    Fd&c blue no. 1 ( UNII: H3R47K3TBD)
    Glycerin ( UNII: PDC6A3C0OX)
    Propylene glycol ( UNII: 6DC9Q167V3)
    Water ( UNII: 059QF0KO0R)
    Sodium benzoate ( UNII: OJ245FE5EU)
    Sorbitol ( UNII: 506T60A25R)
    Sucralose ( UNII: 96K6UQ3ZD4)

    Product Characteristics

    Color BLUE Flavor MINT

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    OTC monograph final part341 USA

    Labeler - H E B( 007924756)

    Package/label principal display panel

    Compare to active ingredients of Tylenol® Cold Multi-Symptom Nighttime Cool Burst® Liquid

    COLD MULTI-SYMPTOM

    Night Time Cool Ice®

    Acetaminophen Phenylephrine HCl Dextromethorphan HBr Doxylamine Succinate

    Pain Reliever Fever Reducer Nasal Decongestant Cough Suppressant - Antihistamine

    Headache, Fever, Sore Throat Cough

    Nasal Congestion Runny Nose

    GLUTEN FREE

    8 FL OZ (237 mL) Liquid