Hybrid Cf
FDA Label NDC 49804-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hybrid-rx Llc for the product Hybrid Cf (NDC 49804-101). 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 otc - active ingredient, otc - purpose, dosage & administration, inactive ingredient, otc - questions, warnings, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (in each caplet)Acetaminophen 500 mgChlorpheniramine maleate 2 mgPhenylephrine HCl 5 mg

Otc - Purpose

Purposes
Pain reliever/Fever Reducer
Antihistamine
Nasal Decongestant


Dosage & Administration

Directions

Adults: Take 1 to 2 caplets with water every 6 hours as needed; do not take more than 8 caplets in 24 hours or as directed by a doctor.

Inactive Ingredient

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Otc - Questions

Questions? 1-904-367-8437, Monday-Friday, 9am-5pm EST

Warnings

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

more than 8 caplets in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.  Acetaminophen may cause liver damage.

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 product containing any of the above active ingredients.
      • with any other drug containing acetaminophen (prescription or nonprescription).
        • Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives or tranquilizers.

When Using This Product

  • do not use more than directed
    • excitability may occur, especially in children
      • drowsiness may occur
        • avoid alcoholic drinks
          • alcohol, sedatives and tranquilizers may increase the drowsiness
            • use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • redness of swelling is present
  • new symptoms occur
  • symptoms get worse or last for more than 7 days
  • fever gets worse or lasts more than 3 days

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 immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Hybrid Cf

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