Cold Preparation

Cold Preparation

Cold Preparation Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

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

  • more than 6 doses (12 tablespoons or 180 mL) in 24 hours for adults
  • more than 5 doses (5 tablespoons or 75 mL) in 24 hours for children 6-12 years old
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if the user has
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • a sodium-restricted diet
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

When using this product,
  • avoid alcoholic drinks
  • do not use more than directed (see overdose warning)
Stop use and ask a doctor if
  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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: 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) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not use
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if the user has
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • a sodium-restricted diet
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if
  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • cough comes back or occurs, with rash or headache that lasts.

These could be signs of a serious condition.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • fever
    • nasal congestion
    • cough due to minor throat and bronchial irritation

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Cold Preparation Manufacturers


  • Monticello Drug Llc (New Genesis)
    Cold Preparation (Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride) Liquid [Monticello Drug Llc (New Genesis)]

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