DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg)

Inactive Ingredients

Silicon Dioxide Hydroxypropyl Cellulose (1600000 Wamw) Magnesium Stearate Starch, Corn Sodium Starch Glycolate Type A Potato Talc

Identifiers & Packaging

Pill Appearance

Imprint: N74 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-02-26

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each tablet) Acetaminophen USP 325 mg

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

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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.

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor
children 6-11 years	take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor
children under 6 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 in this product

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP 325 mg

Other Information

store at 20° to 25°C (68° to 77°F)
do not use if carton is opened, or seal under cap is torn or missing.

Inactive Ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, sodium starch glycolate, talc

Questions Or Comments?

1-855-274-4122

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by:Aurohealth LLC.

2572 Brunswick Pike, Lawrenceville, NJ 08648

Stop Use and Ask A Doctor If

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

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

Ask A Doctor Before Use If the User Has

liver disease

Ask A Doctor Or Pharmacist Before Use If the User Is

taking the blood thinning drug warfarin

Package Label Principal Display Panel 325 Mg (100 Tablets Bottle)

AUROHEALTH

NDC 58602-754-21

Compare to the active ingredient in Tylenol ^®Regular Strength tablets ^*

See Warnings Information & Directions

REGULAR STRENGTH

AUROPHEN

Acetaminophen Tablets 325 mg

Pain reliever/Fever reducer

100 Tablets

Structured Label Content

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

Purpose

Pain reliever/fever reducer

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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.

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor
children 6-11 years	take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor
children under 6 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 in this product

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP 325 mg

Other Information (Other information)

store at 20° to 25°C (68° to 77°F)
do not use if carton is opened, or seal under cap is torn or missing.

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, sodium starch glycolate, talc

Questions Or Comments? (Questions or comments?)

1-855-274-4122

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by:Aurohealth LLC.

2572 Brunswick Pike, Lawrenceville, NJ 08648

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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.)

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

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

Ask A Doctor Before Use If the User Has (Ask a doctor before use if the user has)

liver disease

Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)

taking the blood thinning drug warfarin

Package Label Principal Display Panel 325 Mg (100 Tablets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle))

AUROHEALTH

NDC 58602-754-21

Compare to the active ingredient in Tylenol ^®Regular Strength tablets ^*

See Warnings Information & Directions

REGULAR STRENGTH

AUROPHEN

Acetaminophen Tablets 325 mg

Pain reliever/Fever reducer

100 Tablets

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (1600000 WAMW)", "unii": "RFW2ET671P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Pain reliever/fever reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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.", "Directions": "do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 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 in this product", "Drug Facts": "Active ingredient (in each tablet) Acetaminophen USP 325 mg", "Other information": "store at 20° to 25°C (68° to 77°F) do not use if carton is opened, or seal under cap is torn or missing.", "Inactive ingredients": "colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, pregelatinized starch, sodium starch glycolate, talc", "Questions or comments?": "1-855-274-4122 DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN Distributed by: Aurohealth LLC. 2572 Brunswick Pike, Lawrenceville, NJ 08648", "Stop use and ask a doctor if": "pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years 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.": "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Ask a doctor before use if the user has": "liver disease", "Ask a doctor or pharmacist before use if the user is": "taking the blood thinning drug warfarin", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle)": "AUROHEALTH NDC 58602-754-21 Compare to the active ingredient in Tylenol ® Regular Strength tablets * See Warnings Information & Directions REGULAR STRENGTH AUROPHEN Acetaminophen Tablets 325 mg Pain reliever/Fever reducer 100 Tablets"}