Notts - Muscle Aches & Pain

Notts - Muscle Aches & Pain
SPL v11
SPL
SPL Set ID e6741300-4573-2580-e053-2a95a90a599c
Route
ORAL
Published
Effective Date 2022-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Talc Magnesium Stearate Microcrystalline Cellulose Lecithin, Soybean Titanium Dioxide Polyvinyl Alcohol, Unspecified Stearic Acid Sodium Starch Glycolate Type A Povidone Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: Notts;650 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-17

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

For 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 650 mg Pain Reliever/Fever Reducer

Directions
  • Do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 1 caplets every 4 to 6 hours
  • do not take more than 6 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 damage may occur if you take:

● more than 4,000 mg of acetaminophen in 24 hours, which isthe maximum daily amount.

● with other drugs containing acetaminophen

● 3 or more alcoholic drinks every day while using this product

Overdose Warning

Do not exceed recommended dosage. In case of overdose, get medical help or contact a Poison Control Center right away. 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, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Sodium Starch Glycolate, Talc, Titanium Dioxide.

Stop Use and Ask A Doctor If
  • pain lasts more than 10 days
  • pain 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™ 8HR*

Muscle Aches & Pain

Acetaminophen

  • Minor Muscle Aches
  • Fever Reducer



Compare to Tylenol® 8HR active ingredients**

NDC 82706-008-01

650 mg each caplet

24 CAPLETS

Principal Display Panel 100 Caplets

NOTTS™ 8HR*

Muscle Aches & Pain

Acetaminophen

  • Minor Muscle Aches
  • Fever Reducer



Compare to Tylenol® 8HR active ingredients**

NDC 82706-008-02

650 mg each caplet

100 CAPLETS

Ask A Doctor Or Pharmacist Before Use If You Are Taking

the blood thinning drug warfarin


Structured Label Content

Uses

For 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 650 mg Pain Reliever/Fever Reducer

Directions
  • Do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 1 caplets every 4 to 6 hours
  • do not take more than 6 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 damage may occur if you take:

● more than 4,000 mg of acetaminophen in 24 hours, which isthe 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 exceed recommended dosage. In case of overdose, get medical help or contact a Poison Control Center right away. 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, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Sodium Starch Glycolate, Talc, Titanium Dioxide.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain lasts more than 10 days
  • pain 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™ 8HR*

Muscle Aches & Pain

Acetaminophen

  • Minor Muscle Aches
  • Fever Reducer



Compare to Tylenol® 8HR active ingredients**

NDC 82706-008-01

650 mg each caplet

24 CAPLETS

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

NOTTS™ 8HR*

Muscle Aches & Pain

Acetaminophen

  • Minor Muscle Aches
  • Fever Reducer



Compare to Tylenol® 8HR active ingredients**

NDC 82706-008-02

650 mg each caplet

100 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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)