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.



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 55106-9

Active ingredient (in each caplet)

Acetaminophen 500 mg

Section 60561-8

Other information

• store between 20-25°C (68-77°F)




Structured Label Content

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

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.



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 55106-9 (55106-9)

Active ingredient (in each caplet)

Acetaminophen 500 mg

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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