Gc Es Apap Liquid

Gc Es Apap Liquid
SPL v3
SPL
SPL Set ID e18294f5-8fd5-4ac6-802c-f6d257e8bee7
Route
ORAL
Published
Effective Date 2025-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Methylparaben Polyethylene Glycol, Unspecified Sucralose Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-24

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
Section 50565-1

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

Section 50568-5

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

When using this product: Do not exceed recommended dose.

Section 50569-3

Ask a doctor before use if you have liver disease

Warnings

Liver Warning: This product contains acetaminophen. The maximum

daily dose of this product is 6 tablespoonfuls in 24 hours.

Severe liver damage may occur if you take

• more than 8 tablespoonfuls (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

Adults and children 12 years of age and older

Take 1-2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours

Children under 12 years

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 are allergic to acetaminophen or any of the inactive ingredients in this product
Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Other Information
  • store at room temperature 15°- 30°C (59°-86°F)
  • protect from freezing
  • protect from light
  • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.
Inactive Ingredients

artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions Or Comments?

1-800-540-3765

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel
Stop Use and Ask A Doctor If
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Active Ingredient (in Each 15ml Tablespoonful)

Acetaminophen 500 mg


Structured Label Content

Uses
  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Section 50565-1 (50565-1)

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

Section 50568-5 (50568-5)

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

When using this product: Do not exceed recommended dose.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Purpose

Pain reliever/Fever reducer

Warnings

Liver Warning: This product contains acetaminophen. The maximum

daily dose of this product is 6 tablespoonfuls in 24 hours.

Severe liver damage may occur if you take

• more than 8 tablespoonfuls (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

Adults and children 12 years of age and older

Take 1-2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours

Children under 12 years

Do not use

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 are allergic to acetaminophen or any of the inactive ingredients in this product
Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • store at room temperature 15°- 30°C (59°-86°F)
  • protect from freezing
  • protect from light
  • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.
Inactive Ingredients (Inactive ingredients)

artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Active Ingredient (in Each 15ml Tablespoonful) (Active ingredient (in each 15mL Tablespoonful))

Acetaminophen 500 mg


Advanced Ingredient Data


Raw Label Data

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