Notts - Extra Strength 500 Mg

Notts - Extra Strength 500 Mg
SPL v12
SPL
SPL Set ID e677f43d-b4ce-e5b0-e053-2a95a90ad67e
Route
ORAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Polyvinyl Alcohol, Unspecified Magnesium Stearate Polyethylene Glycol, Unspecified Microcrystalline Cellulose Lecithin, Soybean Sodium Starch Glycolate Type A Titanium Dioxide Talc Povidone Stearic Acid Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: Notts;500 Shape: oval Color: white 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 minor aches and pains due to:

● common cold

● headache

● toothache

● muscular aches

● backaches

● premenstrual and menstrual cramps

● minor pain from arthritis

Temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 55105-1
Active ingredient (in each caplet) Purpose
Acetaminophen 500 mg Pain Reliever/Fever Reducer

Directions
  • Do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 6 hours
  • do not take more than 8 caplets in 24 hours, or as directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor
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.
  • if you are allergic to acetaminophen or any of the inactive ingredients.
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 than 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.
  • Tamper-evident: Do not use if the bottle cap is open or if the foil inner seal is broken or missing.
Inactive Ingredients

Croscarmellose Sodium, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Sodium Starch Glycolate, Talc, Titanium Dioxide.

Principal Display 50 Caplets

NOTTS™

Extra Strength

Acetaminophen

Pain Reliever

Fever Reducer



Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-06

500 mg each caplet

50 CAPLETS

Extra Strength.

25 blisters of 2 caplets each

500 mg each

Stop Use and Ask A Doctor If
  • pain lasts more than 10 days
  • fever lasts more than 3 days
  • pain or fever 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

Principal Display Panel 24 Caplets

NOTTS™

Extra Strength

Acetaminophen

  • Pain Reliever
  • Fever Reducer



Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-01

500 mg each caplet

24 CAPLETS

Extra Strength.

Principal Display Panel 100 Caplets

NOTTS™

Extra Strength

Acetaminophen

  • Pain Reliever
  • Fever Reducer



Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-02

500 mg each caplet

100 CAPLETS

Extra Strength.

Principal Display Panel 400 Caplets

NOTTS™

Extra Strength

Acetaminophen

  • Pain Reliever
  • Fever Reducer

NDC 82706-007-03

500 mg each caplet

400 CAPLETS

Extra Strength.

Principal Display Panel 2 100 Caplets

NOTTS™

Extra Strength

Acetaminophen

Pain Reliever

Fever Reducer



Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-05

500 mg each caplet

100 CAPLETS

Extra Strength.

50 pouches of 2 caplets each

500 mg each

Ask A Doctor Or Pharmacist Before Use If You Are Taking

the blood thinning drug warfarin


Structured Label Content

Uses

Temporary relief of minor aches and pains due to:

● common cold

● headache

● toothache

● muscular aches

● backaches

● premenstrual and menstrual cramps

● minor pain from arthritis

Temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)
Active ingredient (in each caplet) Purpose
Acetaminophen 500 mg Pain Reliever/Fever Reducer

Directions
  • Do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 6 hours
  • do not take more than 8 caplets in 24 hours, or as directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor
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.
  • if you are allergic to acetaminophen or any of the inactive ingredients.
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 than 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.
  • Tamper-evident: Do not use if the bottle cap is open or if the foil inner seal is broken or missing.
Inactive Ingredients (Inactive ingredients)

Croscarmellose Sodium, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Sodium Starch Glycolate, Talc, Titanium Dioxide.

Principal Display 50 Caplets (Principal display 50 caplets)

NOTTS™

Extra Strength

Acetaminophen

Pain Reliever

Fever Reducer



Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-06

500 mg each caplet

50 CAPLETS

Extra Strength.

25 blisters of 2 caplets each

500 mg each

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain lasts more than 10 days
  • fever lasts more than 3 days
  • pain or fever 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

Principal Display Panel 24 Caplets (PRINCIPAL DISPLAY PANEL - 24 Caplets)

NOTTS™

Extra Strength

Acetaminophen

  • Pain Reliever
  • Fever Reducer



Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-01

500 mg each caplet

24 CAPLETS

Extra Strength.

Principal Display Panel 100 Caplets (PRINCIPAL DISPLAY PANEL - 100 Caplets)

NOTTS™

Extra Strength

Acetaminophen

  • Pain Reliever
  • Fever Reducer



Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-02

500 mg each caplet

100 CAPLETS

Extra Strength.

Principal Display Panel 400 Caplets (PRINCIPAL DISPLAY PANEL - 400 Caplets)

NOTTS™

Extra Strength

Acetaminophen

  • Pain Reliever
  • Fever Reducer

NDC 82706-007-03

500 mg each caplet

400 CAPLETS

Extra Strength.

Principal Display Panel 2 100 Caplets (PRINCIPAL DISPLAY PANEL 2 - 100 Caplets)

NOTTS™

Extra Strength

Acetaminophen

Pain Reliever

Fever Reducer



Compare to Tylenol® Extra Strength active ingredients*

NDC 82706-007-05

500 mg each caplet

100 CAPLETS

Extra Strength.

50 pouches of 2 caplets each

500 mg each

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


Advanced Ingredient Data


Raw Label Data

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