Acetaminophen,dextromethorphan,doxylamine
FDA Label NDC 58805-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Agile Pharmachem for the product Acetaminophen, Dextromethorphan, Doxylamine (NDC 58805-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children., direction, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose

pain reliever

Cough Suppressant

Antihistamine

Uses

pain reliever, cough suppressant and Antihistamine

Warnings

Warnings Failure to follow these warnings could result in serious consequences.

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

  • more than 4 doses in 24 hours which is maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

    • do not use:

    • with any other drug containing acetaminophen (prescription or not prescription). 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 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

      • liver disease
      • Heart disease
      • Thyroid disease
      • Diabetes
      • High blood pressure
      • Trouble urinating due to enlarged prostate gland

        • ask your 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:

          • Redness or swelling is present
          • You get nervous, dizzy or sleepless
          • Fever gets worse or lasts more than 3 days
          • New symptoms occur
          • Symptoms do not get better within 7 days or are accompanied by a fever

Keep Out Of Reach Of Children.

If pregnant or breast-feeding, ask a health professional before use.

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

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Direction

  • do not exceed 4 doses per 24 hours
  • take only as directed – see overdose warning
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • children under 12 years: ask a doctor
  • Children under 4 years: do not use

Other Information

  • store at room temperature

Inactive Ingredients

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Questions Or Comments

Call toll free 1-855-314-1850

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NDC: 58805-003-14  and 58805-003-04

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