Cvs
FDA Label NDC 59779-577

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs (NDC 59779-577). 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 other, active ingredient (in each tablet), purpose, uses, liver warning, do not use, ask a doctor or pharmacist before use if you are, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed By: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket RI 02895

CVS.com

1-800-SHOP CVS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.

Tamper Evident: Do not use if individual pouch is torn or open. This is not a child resistant package. Keep out of reach of children.

Active Ingredient (In Each Tablet)

Acetaminophen 500 mg

Diphenhydramine 25 mg

Purpose

Pain Reliever/fever reducer

Nighttime sleep-aid

Uses

temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness

Liver Warning

This product contains acetaminophen. Severe liver damage can occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you ever had an allergic reaction to this product or any of its ingredients
  • Ask a doctor before use if you have

    • liver disease
    • a breathing problem such as emphysema, or chronic bronchitis
    • trouble urinating due to enlarged prostate gland
    • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • When Using this product

    • drowsiness will occur
    • avoid alcoholic beverages
    • do not drive or operate machinery
    • Stop use and ask a doctor if

      • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
      • pain gets worse or lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • new symptoms occur
      • redness or swelling is present
      • new symptoms occur
      • 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

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see Overdose warning)
  • dissolve tablets fully in 8 oz of water at room temperature
  • do not chew or swallow tablet
  • Adults and children 12 years and over

    • take 2 tablets fully dissolved in 8 oz of water at room temperature at bedtime
    • do not take more than 2 tablets in 24 hours

    children under 12 years

    do not use

Other Information

  • each tablet contains: potassium 156 mg; sodium 165 mg
  • store between 20-25°C (68-77°F). Avoid excessive heat.
  • do not use if individual pouch is torn or open

Inactive Ingredients

anhydrous citric acid, FD&C red 40, flavor, polyethylene glycol, polysorbate, potassium bicarbonate, povidone, simethicone, sodium benzoate, sodium bicarbonate, sucralose

Questions Or Comments

1-866-467-2748

Principal Display Panel

Effervescent Pain Relief PM

Extra Strength

Acetaminophen 500mg, Diphenhydramine HCl 25mg

Compare to the active ingredient in Extra Strength Tylenol® PM**

Non-habit forming pain reliever/sleep aid

Aspirin & Ibuprofen free

For a restful night's sleep

No need to chew or swallow tablet

Berry flavor
16 Effervescent Tablets

Cvs Effervescent Pain Relief Pm (177be16cvsfc)

Cvs Effervescent Pain Relief Pm (177be16cvsfc)

* Please review the disclaimer below.