SPL v2
SPL
SPL Set ID 16d5786c-2346-f970-e063-6394a90a0a8c
Route
ORAL
Published
Effective Date 2024-07-03
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Ammonia Ferrosoferric Oxide Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Fd&c Red No. 3 Gelatin, Unspecified Hydroxypropyl Cellulose (110000 Wamw) Magnesium Stearate Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Polyethylene Glycol 4000 Povidone K90 Starch, Corn Propylene Glycol Shellac Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: T;6 Shape: capsule Color: blue Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-28

Description

Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg

Uses

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

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 gelcaps at bedtime
    • do not take more than 2 gelcaps of this product in 24 hours.
  • children under 12 years: do not use
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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • in children under 12 years of age
Drug Facts

Active ingredients (in each gelcap)



Acetaminophen USP 500 mg

Diphenhydramine hydrochloride USP 25 mg

Other Information
  • avoid high humidity
  • store at 20º to 25°C (68º to 77°F)
  • use by expiration date on package
Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

Questions Or Comments?

call 1-888-287-1915 (Monday-Friday 8:30 AM to 5:00 PM EST)



DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716



PRODUCT OF INDIA

When Using This Product
  • drowsiness will occur
  • avoid alcoholic beverages
  • 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
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

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.

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

Ask A Doctor Before Use If You Have
  • liver disease.
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to 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
Package Label Principal Display Panel 500 Mg/25 Mg (80 Gelcaps Bottle)

equate



NDC 79903-267-80



Compare to

Extra Strength

Tylenol® PM

    active

ingredients*



EXTRA STRENGTH



Pain Reliever PM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg



Pain Reliever/Nighttime Sleep-Aid

Non-habit forming



Actual Size



80

GELCAPS






Structured Label Content

Uses

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

Purpose

Pain reliever

Nighttime sleep-aid

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 gelcaps at bedtime
    • do not take more than 2 gelcaps of this product in 24 hours.
  • children under 12 years: do not use
Do Not Use (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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • in children under 12 years of age
Drug Facts

Active ingredients (in each gelcap)



Acetaminophen USP 500 mg

Diphenhydramine hydrochloride USP 25 mg

Other Information (Other information)
  • avoid high humidity
  • store at 20º to 25°C (68º to 77°F)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

Questions Or Comments? (Questions or comments?)

call 1-888-287-1915 (Monday-Friday 8:30 AM to 5:00 PM EST)



DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716



PRODUCT OF INDIA

When Using This Product (When using this product)
  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease.
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Package Label Principal Display Panel 500 Mg/25 Mg (80 Gelcaps Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg/25 mg (80 Gelcaps Bottle))

equate



NDC 79903-267-80



Compare to

Extra Strength

Tylenol® PM

    active

ingredients*



EXTRA STRENGTH



Pain Reliever PM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg



Pain Reliever/Nighttime Sleep-Aid

Non-habit forming



Actual Size



80

GELCAPS






Advanced Ingredient Data


Raw Label Data

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