Equate Pain Relief Pm Solution
FDA Label NDC 79903-421

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Equate Pain Relief Pm (NDC 79903-421). 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 ingredients (in each 30 ml), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 30 Ml)

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Purpose

Pain reliever

Nighttime sleep-aid

Use

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may 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

    • 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.

      Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or

      followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • if you have 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
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Stop Use And Ask A Doctor If

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

  • take only one dose (30 mL) per day (24 hours)
  • only use the dose cup provided
  • take only as directed – see Overdose warning

    • adults & children 12 yrs & over

    30 mL at bedtime

    children under 12 yrs

    do not use

Other Information

  • each 30 mL contains: sodium 25 mg
  • store at 20-25°C (68-77°F)

Inactive Ingredients

alcohol, anhydrous citric acid, benzyl alcohol, FD&C blue #1, FD&C red #40, flavor, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

1-888-287-1915

Package/Label Principal Display Panel

equate™

Compare to Vicks® PainQuil® PM active ingredients

MAXIMUM STRENGTH

Pain Relief PM

Acetaminophen

Diphenhydramine HCl

Pain Reliever/Nighttime Sleep-Aid

Starts Working Fast

Relief of:

• Aches

• Pains

• Headache

• Sore throat + Occasional sleeplessness

Adults

Midnight Cherry Flavor

12 FL OZ (355 mL)

10% ALCOHOL

59z-2e-pain-relief-pm.jpg (59z 2e Pain Relief Pm)

59z-2e-pain-relief-pm.jpg (59z 2e Pain Relief Pm)

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