Pain Relief Pm

Pain Relief Pm
SPL v2
SPL
SPL Set ID 0181af13-da32-4431-be39-c31fdfac9202
Route
ORAL
Published
Effective Date 2024-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Acetaminophen (500 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol Povidone K30 Silicon Dioxide Sodium Starch Glycolate Type A Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: P525 Shape: capsule Color: blue Size: 27 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-29

Description

Acetaminophen 500 mg Diphenhydramine 25 mg

Purpose

Acetaminophen 500 mg ....................................................................................................................................Pain reliever Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid


Medication Information

Purpose

Acetaminophen 500 mg ....................................................................................................................................Pain reliever

Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine 25 mg

Uses:
  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 42229-5

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare

Division., owner of the registered trademark Tylenol® Extra Strength Tablets.

Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Overdose warning: In case of overdose, get medical help or contact Poison Control (1-800-222-1222) right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51945-4

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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.

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 have ever had an allergic reaction to this product or any of its ingredients.

Directions:

■ do not take more than directed (see overdose warning) adults and children 12 years and over

■ take 2 caplets at bedtime

■ do not take more than 2 caplets in 24 hours unless directed by a doctor

■ children under 12 years do not use

Other Information:
  • store at 20°-25°C (68°-77°F)
  • do not use if foil or inner seal is broken or missing

Inactive Ingredients:

Croscarmellose Sodium, FD & C Blue#1 Aluminium Lake, FD &C Blue#2

Aluminium Lake, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene

Glycol, Polyvinyl Alcohol, Povidone K30, Purified Water, Silicon Dioxide, Sodium Starch Glycolate,

Starch Corn, Talc, Titanium Dioxide.

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com

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 serious underlying medical illness.

■ 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. These could be signs of a serious condition.

If Pregnant Or Breast Feeding

ask a health professional before use.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine 25 mg

Ask A Doctor Before Use If You Have:

■ liver disease

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland.

Ask A Doctor Or Pharmacist Before Use If You Are 
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses:
  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 42229-5 (42229-5)

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare

Division., owner of the registered trademark Tylenol® Extra Strength Tablets.

Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Overdose warning: In case of overdose, get medical help or contact Poison Control (1-800-222-1222) right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51945-4 (51945-4)

Purpose

Acetaminophen 500 mg ....................................................................................................................................Pain reliever

Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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.

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 ■ in children under 12 years of age ■ if you have ever had an allergic reaction to this product or any of its ingredients.

Directions:

■ do not take more than directed (see overdose warning) adults and children 12 years and over

■ take 2 caplets at bedtime

■ do not take more than 2 caplets in 24 hours unless directed by a doctor

■ children under 12 years do not use

Other Information:
  • store at 20°-25°C (68°-77°F)
  • do not use if foil or inner seal is broken or missing

Inactive Ingredients:

Croscarmellose Sodium, FD & C Blue#1 Aluminium Lake, FD &C Blue#2

Aluminium Lake, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene

Glycol, Polyvinyl Alcohol, Povidone K30, Purified Water, Silicon Dioxide, Sodium Starch Glycolate,

Starch Corn, Talc, Titanium Dioxide.

Questions Or Comments? (Questions or Comments?)

Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com

When Using This Product (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 (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

■ redness or swelling is present

■ new symptoms occur. These could be signs of a serious condition.

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

ask a health professional before use.

Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine 25 mg

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

■ liver disease

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland.

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

Advanced Ingredient Data


Raw Label Data

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