Acetaminophen 500mg Rapid Release Gelcaps

Acetaminophen 500mg Rapid Release Gelcaps
SPL v5
SPL
SPL Set ID 181aee35-8fb2-35e4-e063-6394a90a6b3b
Route
ORAL
Published
Effective Date 2024-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Isopropyl Alcohol Polyethylene Glycol, Unspecified Fd&c Yellow No. 6 Ferric Oxide Yellow Ferric Oxide Red Stearic Acid Ammonia Fd&c Red No. 40 Titanium Dioxide Hypromellose 2208 (100 Mpa.s) Ferrosoferric Oxide Hydroxymethyl Cellulose Shellac D&c Red No. 33 Butyl Alcohol Silicon Dioxide Propylene Glycol Gelatin Croscarmellose Sodium Fd&c Blue No. 1 Povidone

Identifiers & Packaging

Pill Appearance
Imprint: G1 Shape: oval Color: gray Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-09

Description

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 500 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 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  take 2 gelcaps every 6 hours while symptoms last

children 12 years

and over  do not take more than 6 gelcaps 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

Other Information

 store at 20°-25°C (68°-77°F)

 avoid high humidity

 see end panel for expiration date and lot number

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.

Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red

#40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene

glycol, povidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide,

yellow iron oxide

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel

Principal Display Panel

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

Keep out of reach of children

Active Ingredient (in Each Gelcap)

Acetaminophen USP, 500 mg

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


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 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  take 2 gelcaps every 6 hours while symptoms last

children 12 years

and over  do not take more than 6 gelcaps 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

Other Information (Other information)

 store at 20°-25°C (68°-77°F)

 avoid high humidity

 see end panel for expiration date and lot number

Overdose Warning: (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.

Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red

#40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene

glycol, povidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide,

yellow iron oxide

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel

Principal Display Panel (Principal Display panel)

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)

Keep out of reach of children

Active Ingredient (in Each Gelcap) (Active ingredient (in each gelcap))

Acetaminophen USP, 500 mg

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)