DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Povidone K30 Starch, Corn Palmitostearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: N79 Shape: capsule Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-09-02

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

Uses

• temporarily relieves minor aches and pains due to:

• the common cold

• headache

• backache

• minor pain of arthritis

• toothache

• muscular aches

• premenstrual and menstrual cramps

• temporarily reduces fever

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.

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

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 caplet)

Acetaminophen USP 500 mg

Other Information

store between 20° to 25°C (68° to 77°F)
do not use if printed foil seal under cap is torn or missing.

Inactive Ingredients

povidone, pregelatinized starch (maize), stearic acid.

Questions Or Comments?

call 1-855-274-4122

Distributed by:

AUROHEALTH LLC.

279 Princeton- Hightstown Road,

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

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.

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.

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Package Label Principal Display Panel 500 Mg (750 Caplets Bottle)

NDC 58602-776-88Primary Health

Compare to the active ingredient in

Tylenol ^® Extra strength Caplets ^*

See New Warnings Information & Directions

EXTRA STRENGTH

For Adults

Pain Relief

Acetaminophen Caplets 500 mg

Pain reliever/Fever reducer

N 79

750 CAPLETS

500 mg each

Structured Label Content

Uses

• temporarily relieves minor aches and pains due to:

• the common cold

• headache

• backache

• minor pain of arthritis

• toothache

• muscular aches

• 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 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.

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

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 caplet)

Acetaminophen USP 500 mg

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)
do not use if printed foil seal under cap is torn or missing.

Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized starch (maize), stearic acid.

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

Distributed by:

AUROHEALTH LLC.

279 Princeton- Hightstown Road,

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

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.)

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Package Label Principal Display Panel 500 Mg (750 Caplets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle))

NDC 58602-776-88Primary Health

Compare to the active ingredient in

Tylenol ^® Extra strength Caplets ^*

See New Warnings Information & Directions

EXTRA STRENGTH

For Adults

Pain Relief

Acetaminophen Caplets 500 mg

Pain reliever/Fever reducer

N 79

750 CAPLETS

500 mg each

Advanced Ingredient Data

[{"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PALMITOSTEARIC ACID", "unii": "Q8Y7S3B85M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • 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 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.", "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", "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 caplet) Acetaminophen USP 500 mg", "Other information": "store between 20° to 25°C (68° to 77°F) do not use if printed foil seal under cap is torn or missing.", "Inactive ingredients": "povidone, pregelatinized starch (maize), stearic acid.", "Questions or comments?": "call 1-855-274-4122 Distributed by: AUROHEALTH LLC. 279 Princeton- Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014", "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.": "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.", "Ask a doctor before use if you have": "liver disease", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)": "NDC 58602-776-88 Primary Health Compare to the active ingredient in Tylenol ® Extra strength Caplets * See New Warnings Information & Directions EXTRA STRENGTH For Adults Pain Relief Acetaminophen Caplets 500 mg Pain reliever/Fever reducer N 79 750 CAPLETS 500 mg each"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information