251

251
SPL v5
SPL
SPL Set ID e65dbd01-2d5e-4067-ad98-98d879cfb5ee
Route
ORAL
Published
Effective Date 2013-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Hydroxypropyl Cellulose Hypromelloses Ferrosoferric Oxide Polyethylene Glycol, Unspecified Povidone Propylene Glycol Shellac Starch, Corn Stearic Acid Titanium Dioxide Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: L5 Shape: capsule Color: red Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-06-01

Description

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer


Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains

  • temporarily reduces fever
Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 8 gelcaps (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.

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

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.

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.

Directions
  • do not take more than directed
  • adults and children 12 years and over: Take 2 gelcaps every

6 hours, as needed; not more than 6 gelcaps in 24 hours.

Do not take for more than 10 days unless directed by a doctor.

  • children under 12 years: ask a doctor
Package Label

Other Information
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • avoid high humidity

Inactive Ingredients

Croscarmellose Sodium, D and C Red 33, FD and C Blue 1, FD and C Red 40, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide, PEG, Povidone, Propylene Glycol, Shellac Glaze, Starch, Stearic Acid, Titanium Dioxide.

Keep Out of Reach of Children

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Gelcap)

Acetaminophen 500 mg


Structured Label Content

Uses
  • temporarily relieves minor aches and pains

  • 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 8 gelcaps (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.

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

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.

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.

Directions
  • do not take more than directed
  • adults and children 12 years and over: Take 2 gelcaps every

6 hours, as needed; not more than 6 gelcaps in 24 hours.

Do not take for more than 10 days unless directed by a doctor.

  • children under 12 years: ask a doctor
Package Label (Package label)

Other Information
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • avoid high humidity

Inactive Ingredients

Croscarmellose Sodium, D and C Red 33, FD and C Blue 1, FD and C Red 40, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide, PEG, Povidone, Propylene Glycol, Shellac Glaze, Starch, Stearic Acid, Titanium Dioxide.

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

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Acetaminophen 500 mg


Advanced Ingredient Data


Raw Label Data

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