697r timely 49483-697 extra strength acetaminophen 500 mg rapid release 400 count

697r timely 49483-697 extra strength acetaminophen 500 mg rapid release 400 count
SPL v3
SPL
SPL Set ID c9f80d24-bd05-e1ce-e053-2995a90aa646
Route
oral
Published
Effective Date 2022-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
fd&c yellow no. 6 aluminum lake hypromellose 2910 (6 mpa.s) polyethylene glycol 400 croscarmellose sodium crospovidone fd&c red no. 40 aluminum lake polysorbate 80 polyethylene glycol 6000 mica povidone k30 magnesium stearate starch, corn

Identifiers & Packaging

Pill Appearance
Imprint: TCL;A71 Shape: capsule Color: red Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-02-11

Description

Active ingredient (in each caplet) Acetaminophen 500 mg


Medication Information

Warnings and Precautions

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours

• 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.



Active Ingredient

Active ingredient (in each caplet)

Acetaminophen 500 mg

Indications and Usage

Uses

temporarily relieves minor aches and pains due to:

• headache

• muscular aches

• backache

• minor pain of arthritis

• the common cold

• toothache

• 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 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children under 12 years:

  • ask a doctor

Description

Active ingredient (in each caplet) Acetaminophen 500 mg

Section 50565-1

Keep out of reach of children.

Overdose warning: 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 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.

• if you are allergic to acetaminophen or any of the inactive ingredients in this product



Section 51727-6

Inactive ingredients croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, mica based pearlescent pigment, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 60561-8

Other information

• store between 20-25°C (68-77°F)




Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours

• 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.



Active Ingredient (55106-9)

Active ingredient (in each caplet)

Acetaminophen 500 mg

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to:

• headache

• muscular aches

• backache

• minor pain of arthritis

• the common cold

• toothache

• 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 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

children under 12 years:

  • ask a doctor

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: 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 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.

• if you are allergic to acetaminophen or any of the inactive ingredients in this product



Section 51727-6 (51727-6)

Inactive ingredients croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, mica based pearlescent pigment, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 60561-8 (60561-8)

Other information

• store between 20-25°C (68-77°F)




Advanced Ingredient Data


Raw Label Data

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