Acetaminophen Caplets

Acetaminophen Caplets
SPL v2
SPL
SPL Set ID 57fff3dc-ba30-4d3d-9362-01df6974f813
Route
ORAL
Published
Effective Date 2017-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Castor Oil Hypromellose, Unspecified Povidone Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;175 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Act

Acetaminophen 500 mg

Uses

_ temporarily relieves 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

Drug Facts (continued)

Section 42229-5

Drug Facts

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: _ rash _ blisters

_ skin reddening If a skin reaction occurs, stop use and seek medical help right away.

Directions

_ do not take more than directed

_ 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 take for more than 10 days unless directed by a doctor

_ children under 12 years: ask a doctor

Do Not Use

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

_ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug

Drug Facts (continued)

contains acetaminophen, ask a doctor or pharmacist.

Other Information

_ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

_ use by expiration date on package

Drug Facts (continued)

Inactive Ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments?

1-800-901-2420

Dist. by Breeden Brothers, LLC

Nashville, TN 37219

Ask A Doctor Before Use

if you have liver disease.

Principal Display Panel

b+b

better by giving

EXTRA STRENGTH

PAIN RELIEVER

acetaminophen

Pain Reliever/Fever Reducer

50 Caplets

(500 mg each)

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is

Drug Facts (continued)

critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use

if you are taking the blood thinning drug warfarin.


Structured Label Content

Act

Acetaminophen 500 mg

Uses

_ temporarily relieves 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

Drug Facts (continued)

Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain reliever/fever reducer

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: _ rash _ blisters

_ skin reddening If a skin reaction occurs, stop use and seek medical help right away.

Directions

_ do not take more than directed

_ 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 take for more than 10 days unless directed by a doctor

_ children under 12 years: ask a doctor

Do Not Use (Do not use)

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

_ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug

Drug Facts (continued)

contains acetaminophen, ask a doctor or pharmacist.

Other Information (Other information)

_ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

_ use by expiration date on package

Drug Facts (continued)

Inactive Ingredients (Inactive ingredients)

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-901-2420

Dist. by Breeden Brothers, LLC

Nashville, TN 37219

Ask A Doctor Before Use (Ask a doctor before use)

if you have liver disease.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

b+b

better by giving

EXTRA STRENGTH

PAIN RELIEVER

acetaminophen

Pain Reliever/Fever Reducer

50 Caplets

(500 mg each)

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is

Drug Facts (continued)

critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking the blood thinning drug warfarin.


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