Counteract Pain Content Of Labeling

Counteract Pain Content Of Labeling
SPL v3
SPL
SPL Set ID 7faf76b4-7f25-377d-e053-2a91aa0a19d4
Route
ORAL
Published
Effective Date 2011-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Titanium Dioxide Hypromelloses Polyethylene Glycol Povidone Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-02

Description

Active Ingredients (in each caplet) Acetaminophen 500 mg


Medication Information

Recent Major Changes

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Warnings and Precautions

Warnings

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

  • more than 8 caplets 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

Indications and Usage

Uses

  • for the temporary relief of minor aches and pains due to:
    • headache
    • the common cold
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever



Dosage and Administration

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 to 6 hours while symptoms last
    • do not take more than 8 caplets in 24 hours
    • do not take more than 10 days unless directed by a doctor
  • children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Description

Active Ingredients (in each caplet) Acetaminophen 500 mg

Section 34088-5

Overdose warning:  Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 44425-7

Other information

  • store at room temperature

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if:

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur redness or swelling is present

These could be signs of a serious condition

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have

  • liver disease
Section 50570-1

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.
Section 51727-6

Inactive ingredients  Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Section 51945-4

Section 53413-1

Questions or comments?  If you have any questions or comments, or to report and adverse event, please contact 1-800-282-3000.

Section 53414-9

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

Section 55105-1

Purposes

Pain Reliever/fever reducer

Section 55106-9

Active Ingredients (in each caplet)

Acetaminophen 500 mg


Structured Label Content

Recent Major Changes (34066-1)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Indications and Usage (34067-9)

Uses

  • for the temporary relief of minor aches and pains due to:
    • headache
    • the common cold
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever



Dosage and Administration (34068-7)

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 to 6 hours while symptoms last
    • do not take more than 8 caplets in 24 hours
    • do not take more than 10 days unless directed by a doctor
  • children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Warnings and Precautions (34071-1)

Warnings

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

  • more than 8 caplets 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

Section 34088-5 (34088-5)

Overdose warning:  Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 44425-7 (44425-7)

Other information

  • store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur redness or swelling is present

These could be signs of a serious condition

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients  Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?  If you have any questions or comments, or to report and adverse event, please contact 1-800-282-3000.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Pain Reliever/fever reducer

Section 55106-9 (55106-9)

Active Ingredients (in each caplet)

Acetaminophen 500 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)