Excinol Extra 500 Mg

Excinol Extra 500 Mg
SPL v2
SPL
SPL Set ID 830116e4-467b-4206-a5a0-40ca2d24df5e
Route
ORAL
Published
Effective Date 2020-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Carnauba Wax Hypromellose, Unspecified Polyethylene Glycol, Unspecified Propylene Glycol Povidone Starch, Corn Stearic Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-06

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • backache
  • minor pain of arthritis
  • temporarily reduces fever
  • the common cold
  • toothache
  • menstrual cramps
  • muscular aches
Section 50565-1

Keep out of reach of children.

Section 50566-9

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 appear
  • redness or swelling is present

These could be signs of a serious condition

Section 50568-5

Ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have liver disease

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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.
Directions

do not take more than directed (see overdose warning).

Adults and children 12 years and over:

  • take 2 caplets every 4 to 6 hours
  • Do not take more than 8 caplets of this product in 24 hours.

Children under 12 years:

  • do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Do Not Use
  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.
Overdose Warning

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. (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.

Active Ingredient

Acetaminophen 500 mg

Other Information
  • store at 25°C (77°F)
  • see end panel for lot number and expiration date
Excinol Extra 500 Mg

Drug Facts

Inactive Ingredients
  • Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions Or Comments?

call toll free 1-855-470-6722


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • backache
  • minor pain of arthritis
  • temporarily reduces fever
  • the common cold
  • toothache
  • menstrual cramps
  • muscular aches
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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 appear
  • redness or swelling is present

These could be signs of a serious condition

Section 50568-5 (50568-5)

Ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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.
Directions

do not take more than directed (see overdose warning).

Adults and children 12 years and over:

  • take 2 caplets every 4 to 6 hours
  • Do not take more than 8 caplets of this product in 24 hours.

Children under 12 years:

  • do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.
Overdose Warning (Overdose warning)

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. (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.

Active Ingredient

Acetaminophen 500 mg

Other Information (Other information)
  • store at 25°C (77°F)
  • see end panel for lot number and expiration date
Excinol Extra 500 Mg (Excinol Extra 500 mg)

Drug Facts

Inactive Ingredients (Inactive ingredients)
  • Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions Or Comments? (Questions or comments?)

call toll free 1-855-470-6722


Advanced Ingredient Data


Raw Label Data

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