Extra Strength Pain Relief Pm
FDA Label NDC 68210-0099

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceutical Llc for the product Extra Strength Pain Relief Pm (NDC 68210-0099). 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, otc - purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

DISTRIBUTED BY:

SPIRIT PHARMACEUTICALS, LLC.

RONKONKOMA, NY 11779

Otc - Purpose

Active ingredients (in each caplet)Purpose
Acetaminophen 500mgPain reliever
Diphenhydramine HCl 25mgNighttime Sleep aid

Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Liver Warning

This product contains acetaminophen. Severe liver damage may occur with this product 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 you are using this product

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

    • If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

  • with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • in children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have

  • liver disease
  • breathing problems such as emphysema or chronic bronchitis
  • trouble urinating due to an enlargement of the 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 drinks
  • do not drive a motor vehicle or operate machinery.

Stop Use And Ask A Doctor If

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

    • These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the directed dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (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)

    adults and children 12 years of age and over:
    • take 2 caplets at bedtime or as directed by a doctor
    • do not take more than 2 caplets in a 24 hour period
    children under 12 years of age:
    • do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

  • each caplet contains: magnesium 0.05 mg
  • store between 20°-25°C (68°-77°F)
  • see end panel for lot number and expiration

Inactive Ingredients

FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

1-888-333-9792

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VALUMEDS™

SEE NEW WARNINGS INFORMATION

Compare to the active ingredients in

EXTRA STRENGTH TYLENOL®PM*

EXTRA STRENGTH

PAIN RELIEF PM

PAIN RELIEVER NIGHTTIME SLEEP AID

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

* Please review the disclaimer below.