Misoprostol label

Misoprostol

Misoprostol Recall

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Side Effects & Adverse Reactions

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

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • 3 or more alcoholic drinks every day while using this product
  • 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.
  • 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 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

Ask a doctor before use if you have

  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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

  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur
  • cough comes back or occurs with rash or headache that lasts
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

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) right away. 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

  • 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 Parkinson’s disease), or for 2 weeks after stopping 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

Ask a doctor before use if

Ask a doctor before use if you have

  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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.

Stop use and ask a doctor if

  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur
  • cough comes back or occurs with rash or headache that lasts
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition. 

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FDA Safety Alerts

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

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Manufacturer Warnings

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

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FDA Labeling Changes

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

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Uses

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • headache
    • minor aches and pains
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive 
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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

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Misoprostol Manufacturers

  • Cardinal Health
    Misoprostol | Meijer
    No Recall

    Misoprostol | Meijer

    Misoprostol | Meijer
    do not take more than directed (see overdose warning) do not take more than 12 caplets in any 24-hour period adults and children 12 years and older: take 2 caplets every 4 hours children under 12 years of age: do not use
  • Apotheca, Inc.
    Misoprostol | Apotheca, Inc.
    No Recall

    Misoprostol | Apotheca, Inc.

    Misoprostol | Apotheca, Inc.

    The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

  • Pd-rx Pharmaceuticals, Inc.
    Misoprostol | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Misoprostol | Pd-rx Pharmaceuticals, Inc.

    Misoprostol | Pd-rx Pharmaceuticals, Inc.

    The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

  • H.j. Harkins Company, Inc.
    Misoprostol | H.j. Harkins Company, Inc.
    No Recall

    Misoprostol | H.j. Harkins Company, Inc.

    Misoprostol | H.j. Harkins Company, Inc.

    The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

  • Gavis Pharmaceuticals, Llc
    Misoprostol | Gavis Pharmaceuticals, Llc
    No Recall

    Misoprostol | Gavis Pharmaceuticals, Llc

    Misoprostol | Gavis Pharmaceuticals, Llc

    The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

  • Novel Laboratories, Inc.
    Misoprostol | Novel Laboratories, Inc.
    No Recall

    Misoprostol | Novel Laboratories, Inc.

    Misoprostol | Novel Laboratories, Inc.

    The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

  • Genbiopro Inc
    Misoprostol | Genbiopro Inc
    No Recall

    Misoprostol | Genbiopro Inc

    Misoprostol | Genbiopro Inc

    The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

  • Pd-rx Pharmaceuticals, Inc.
    Misoprostol | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Misoprostol | Pd-rx Pharmaceuticals, Inc.

    Misoprostol | Pd-rx Pharmaceuticals, Inc.

    The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

  • Pharmacist Pharmaceutical, Llc
    Misoprostol | Pharmacist Pharmaceutical, Llc
    No Recall

    Misoprostol | Pharmacist Pharmaceutical, Llc

    Misoprostol | Pharmacist Pharmaceutical, Llc

    The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

  • Clinical Solutions Wholesale
    Misoprostol | Clinical Solutions Wholesale
    No Recall

    Misoprostol | Clinical Solutions Wholesale

    Misoprostol | Clinical Solutions Wholesale

    The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used (see Clinical Pharmacology: Clinical studies). Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated (see Clinical Pharmacology).

  • American Health Packaging
    Misoprostol | American Health Packaging
    No Recall

    Misoprostol | American Health Packaging

    Misoprostol | American Health Packaging

    The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

  • Dispensing Solutions, Inc.
    Misoprostol | Dispensing Solutions, Inc.
    No Recall

    Misoprostol | Dispensing Solutions, Inc.

    Misoprostol | Dispensing Solutions, Inc.

    The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used (see Clinical Pharmacology: Clinical studies). Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated (see Clinical Pharmacology).

  • Aidarex Pharmaceuticals Llc
    Misoprostol | Aidarex Pharmaceuticals Llc
    No Recall

    Misoprostol | Aidarex Pharmaceuticals Llc

    Misoprostol | Aidarex Pharmaceuticals Llc

    The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

  • Readymeds
    Misoprostol | Readymeds
    No Recall

    Misoprostol | Readymeds

    Misoprostol | Readymeds

    The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

  • Greenstone Llc
    Misoprostol | Greenstone Llc
    No Recall

    Misoprostol | Greenstone Llc

    Misoprostol | Greenstone Llc

    The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used (see Clinical Pharmacology: Clinical studies). Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated (see Clinical Pharmacology).

  • Bryant Ranch Prepack
    Misoprostol | Bryant Ranch Prepack
    No Recall

    Misoprostol | Bryant Ranch Prepack

    Misoprostol | Bryant Ranch Prepack

    The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See CLINICAL PHARMACOLOGY, Clinical Studies). Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal Impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See CLINICAL PHARMACOLOGY).

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