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Drug Facts


Active ingredients (in each 10 mL)

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Purposes

Pain reliever/fever reducer 

Cough suppressant

Expectorant

Nasal decongestant


Uses

  • temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritationthe intensity of coughingthe impulse to cough to help your child get to sleepnasal congestionstuffy nosesore throatminor aches and painsheadache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you child takes:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

  • more than 5 doses in 24 hours,which is the maximum daily amount
  • with other drugs containing acetaminophen

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.
  • 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

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

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfain


When using this product,

do not use more than directed (see Overdose warning).


Stop use and ask a doctor if

These could be signs of a serious condition.

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 5 days
  • redness or swelling is present
  • new symptoms occur
  • fever get worse or lasts more than 3 days
  • cough comes back, or occurs with rash or headache that lasts.

Keep out of reach of children.

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


Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • do not give more than 5 doses in any 24-hour period
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 days unless directed by a doctor
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • children 6 to under 12 years of age: 10 mL in dosing cup provided
  • children under 6 years of age: do not use

Other information

  • each 10 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, disodium EDTA,, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum


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