Daytime cold reliefmulti symptom tablet, film coated

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

  1. for the temporary relief of the following cold/flu symptoms:
  2. minor aches and pains
  3. headache
  4. sore throat
  5. nasal congestion
  6. cough
  7. impulse to cough
  8. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  9. temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  1. more than 12 caplets in 24 hours, which is the maximum daily amount
  2. with other drugs containing acetaminophen
  3. 3 or more alcoholic drinks every day while using this product

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

  1. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  2. 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.

Ask a doctor before use if you have

  1. liver disease
  2. heart disease
  3. high blood pressure
  4. thyroid disease
  5. diabetes
  6. trouble urinating due to an enlarged prostate gland
  7. cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  8. 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 use more than directed

Stop use and ask a doctor if

  1. you get nervous, dizzy or sleepless
  2. pain, nasal congestion or cough gets worse or lasts more than 7 days
  3. fever gets worse or lasts more than 3 days
  4. redness or swelling is present
  5. new symptoms occur
  6. 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.

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

  1. do not take more than directed (see Liver warning)
take 2 caplets every 4 hours
  • swallow whole do not crush, chew or dissolve
  • do not take more than 12 caplets in 24 hoursdo not use this adult product in children under 12 years of age

    adults and children 12 years and over

    children under 12 years

    Other information

    1. each caplet contains: sodium 3 mg

    Inactive ingredients

    acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

    Questions or comments? 1-800-719-9260

    Ingredients and appearance - Product information

    Daytime cold reliefmulti symptom tablet, film coated- Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11822-0308
    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
    Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 200 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)
    Croscarmellose sodium ( UNII: M28OL1HH48)
    Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
    Maltodextrin ( UNII: 7CVR7L4A2D)
    Cellulose, microcrystalline ( UNII: OP1R32D61U)
    Polyethylene glycols ( UNII: 3WJQ0SDW1A)
    Polyvinyl alcohol ( UNII: 532B59J990)
    Povidones ( UNII: FZ989GH94E)
    Silicon dioxide ( UNII: ETJ7Z6XBU4)
    Stearic acid ( UNII: 4ELV7Z65AP)
    Talc ( UNII: 7SEV7J4R1U)
    Titanium dioxide ( UNII: 15FIX9V2JP)

    Product Characteristics

    Color YELLOW Size 20 mm
    Shape OVAL (capsule shaped) Score 1
    Imprint Code L234 Flavor VANILLA (menthol)

    Marketing Information

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

    Labeler - Rite Aid Corporation( 014578892)

    Principal display panel

    Compare to the active ingredients in Tylenol® Cold Multi-Symptom Severe Cool Burst® Caplets

    SEVERE

    multi-symptom

    daytime cold relief

    fever/headache/sore throat (acetaminophen 325 mg)

    nasal congestion (phenylephrine HCl 5 mg)

    coughing (dextromethorphan HBr 10 mg)

    chest congestion (guaifenesin 200 mg)

    NON-DROWSY

    PSEUDOEPHEDRINE FREE

    pain reliever/fever reducer

    nasal decongestant

    cough suppressant

    expectorant

    ACTUAL SIZE

    SEE NEW WARNINGS INFORMATION

    COOL ICE®

    INSTANT COOLING SENSATION

    Daytime Cold Relief Carton Image 1 Daytime Cold Relief Carton Image 1

    Daytime Cold Relief Carton Image 2