Pain Reliever Pm, Extra Strength, 24/7 Life By 7-eleven Tm

Pain Reliever Pm, Extra Strength, 24/7 Life By 7-eleven Tm
SPL v1
SPL
SPL Set ID 45c7c11b-d627-aee8-e063-6294a90a401d
Route
ORAL
Published
Effective Date 2022-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Acetaminophen (500 mg)
Inactive Ingredients
Silicon Dioxide Talc Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Stearic Acid Titanium Dioxide Polyvinyl Alcohol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 44;235 Shape: oval Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-06

Description

Drug Facts

Purpose

Purpose Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Purpose

Pain reliever

Nighttime sleep-aid

Description

Drug Facts

Uses

Uses

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

Warnings

Warnings

Directions

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
  • children under 12 years: do not use
Do Not Use

Do not use

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

Drug Facts

Allergy Alert

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.

Liver Warning

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
Other Information

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see bottom flap for expiration date and lot number
Active Ingredients

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Inactive Ingredients

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

When Using This Product

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • drowsiness will occur
Stop Use and Ask A Doctor If

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.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • 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 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 an enlarged prostate gland
  • glaucoma
Pain Reliever Pm, Extra Strength, 24/7 Life

[ 24/7 Life by 7-Eleven TM logo]

Extra Strength

Pain

RelieverPM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pain Reliever

Nighttime Sleep-Aid

Non-Habit Forming

compare to Extra

Strength Tylenol ® PM

active ingredients*

6

CAPLETS

[caplet image]

Actual Size

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
Pain Reliever Pm, Extra Strength, 24/7 Life B 7 Eleven Tm

[ 24/7 Life by 7-Eleven TM logo]


Structured Label Content

Uses

Uses

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

Purpose

Purpose

Pain reliever

Nighttime sleep-aid

Warnings

Warnings

Directions

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
  • children under 12 years: do not use
Do Not Use (Do not use)

Do not use

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

Drug Facts

Allergy Alert (Allergy alert)

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.

Liver Warning (Liver warning)

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
Other Information (Other information)

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see bottom flap for expiration date and lot number
Active Ingredients (Active ingredients)

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

When Using This Product (When using this product)

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • drowsiness will occur
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • 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)

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

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

Keep out of reach of children. In case of 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)

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to an enlarged prostate gland
  • glaucoma
Pain Reliever Pm, Extra Strength, 24/7 Life (Pain Reliever PM, Extra Strength, 24/7 Life)

[ 24/7 Life by 7-Eleven TM logo]

Extra Strength

Pain

RelieverPM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pain Reliever

Nighttime Sleep-Aid

Non-Habit Forming

compare to Extra

Strength Tylenol ® PM

active ingredients*

6

CAPLETS

[caplet image]

Actual Size

Ask A Doctor Or Pharmacist Before Use If You Are (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
Pain Reliever Pm, Extra Strength, 24/7 Life B 7 Eleven Tm (Pain reliever PM, Extra Strength, 24/7 Life b 7-Eleven TM)

[ 24/7 Life by 7-Eleven TM logo]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)