Cold multi symptom tablet, film coated

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

  • temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sinus congestion and pressure
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • 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
  • 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

When using this product

do not exceed recommended dosage

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)
take 2 caplets every 4 hours
  • swallow whole do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours

    adults and children 12 years and over

    children under 12 years

    ask a doctor

    Inactive ingredients

    acesulfame potassium, carnauba wax, crospovidone, flavor, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

    Questions or comments?

    1-800-632-6900

    Ingredients and appearance - Product information

    Cold multi symptom tablet, film coated- Acetaminophen, dextromethorphan hbr, phenylephrine hcl

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 30142-623
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
    Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 1
    Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

    Inactive Ingredients

    Ingredient Name Code
    Acesulfame potassium ( UNII: 23OV73Q5G9)
    Carnauba wax ( UNII: R12CBM0EIZ)
    Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
    Microcrystalline cellulose ( UNII: OP1R32D61U)
    Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
    Polyvinyl alcohol, unspecified ( UNII: 532B59J990)
    Povidone, unspecified ( UNII: FZ989GH94E)
    Stearic acid ( UNII: 4ELV7Z65AP)
    Talc ( UNII: 7SEV7J4R1U)
    Titanium dioxide ( UNII: 15FIX9V2JP)

    Product Characteristics

    Color WHITE Size 17 mm
    Shape CAPSULE (caplet) Score 1
    Imprint Code L371 Flavor VANILLA ((menthol))

    Marketing Information

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

    Labeler - Kroger Company( 006999528)

    Principal display panel

    COMPARE TO the active ingredients of TYLENOL® COLD MAX

    See top panel

    DAYTIME NON-DROWSY FOR ADULTS

    Cold Multi-Symptom

    Acetaminophen, Pain Reliever/Fever Reducer

    Phenylephrine HCl, Nasal Decongestant

    Dextromethorphan HBr, Cough Suppressant

    COOL ICE®

    Instant Cooling Sensation

    Relief of:

    Fever, Headache, Sore Throat

    Nasal Congestion

    Coughing

    24 CAPLETS

    actual size