Notts - Pain Relief Pm

Notts - Pain Relief Pm
SPL v9
SPL
SPL Set ID e6754f62-e3b2-773f-e053-2a95a90ad36a
Route
ORAL
Published
Effective Date 2022-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 2 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Titanium Dioxide Stearic Acid Povidone Sodium Starch Glycolate Type A Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: NOTTS;PM Shape: oval Color: blue Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-17

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporary relief of occasional headaches, minor aches and pains with accompanying sleeplessness

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 55105-1
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain Reliever
Diphenhydramine HCl 25 mg Nighttime Sleep Aid
Directions
  • Do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets at bedtime if needed, or as directed by a doctor.
  • do not take more than 2 caplets 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
  • in children under 12 years of age
  • if you are allergic to any other ingredient in this product.
Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • rash
  • blisters

If a skin reaction occurs, stop use and seek medical attention immediately.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Overdose Warning

Do not take more the recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • Store between 20-25°C (68-77°F)
  • Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
Inactive Ingredients

Croscarmellose Sodium, Corn Starch, FD&C Blue No. 1 Aluminium Lake, FD&C Blue No. 2 Aluminium Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Silicon Dioxide, Sodium Starch Glycolate, Talc, Titanium Dioxide.

When Using This Product

avoid alcoholic drinks

Stop Use and Ask A Doctor If
  • sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
  • pain lasts more than 10 days
  • pain gets worse
  • new symptoms occur
  • redness or swelling is present.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have
  • liver disease
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urinatation due to enlargement of the prostate gland
Principal Display Panel 24 Caplets

NOTTS™

Pain Relief PM

Acetaminophen,

Diphenhydramine HCl

​500 mg/ 25 mg each caplet

Pain Reliever

Nighttime Sleep Aid

Non-habit Forming

Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-01

24 CAPLETS

Principal Display Panel 50 Caplets

NOTTS™

Pain Relief PM

Acetaminophen,

Diphenhydramine HCl

500 mg/ 25 mg each caplet

  • Pain Reliever
  • Nighttime Sleep Aid
  • Non-habit Forming



Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-02

50 CAPLETS

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

Structured Label Content

Uses

Temporary relief of occasional headaches, minor aches and pains with accompanying sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain Reliever
Diphenhydramine HCl 25 mg Nighttime Sleep Aid
Directions
  • Do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets at bedtime if needed, or as directed by a doctor.
  • do not take more than 2 caplets 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
  • in children under 12 years of age
  • if you are allergic to any other ingredient in this product.
Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • rash
  • blisters

If a skin reaction occurs, stop use and seek medical attention immediately.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Overdose Warning (Overdose warning)

Do not take more the recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • Store between 20-25°C (68-77°F)
  • Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
Inactive Ingredients (Inactive ingredients)

Croscarmellose Sodium, Corn Starch, FD&C Blue No. 1 Aluminium Lake, FD&C Blue No. 2 Aluminium Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Silicon Dioxide, Sodium Starch Glycolate, Talc, Titanium Dioxide.

When Using This Product (When using this product)

avoid alcoholic drinks

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
  • pain lasts more than 10 days
  • pain gets worse
  • new symptoms occur
  • redness or swelling is present.

These could be signs of a serious condition.

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

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urinatation due to enlargement of the prostate gland
Principal Display Panel 24 Caplets (PRINCIPAL DISPLAY PANEL - 24 Caplets)

NOTTS™

Pain Relief PM

Acetaminophen,

Diphenhydramine HCl

​500 mg/ 25 mg each caplet

Pain Reliever

Nighttime Sleep Aid

Non-habit Forming

Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-01

24 CAPLETS

Principal Display Panel 50 Caplets (PRINCIPAL DISPLAY PANEL - 50 Caplets)

NOTTS™

Pain Relief PM

Acetaminophen,

Diphenhydramine HCl

500 mg/ 25 mg each caplet

  • Pain Reliever
  • Nighttime Sleep Aid
  • Non-habit Forming



Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-02

50 CAPLETS

Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
  • the blood thinning drug warfarin
  • sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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