Acetamax

Acetamax
SPL v1
SPL
SPL Set ID ac8606d3-da20-4936-b8b2-75c418847f4f
Route
ORAL
Published
Effective Date 2020-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Anhydrous Citric Acid Dimethicone Docusate Sodium Ginger Oil West Indian Lemongrass Oil Mannitol Polyethylene Glycol 6000 Povidone K30 Silicon Dioxide Sodium Bicarbonate Sodium Carbonate Sodium Chloride Sodium Citrate Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-31

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 due to:

▪ headache

▪ backache

▪ toothache

▪ the common cold

▪ minor pain of arthritis

▪ muscular aches

▪ premenstrual and menstrual cramps

• temporarily reduces fever

Image

Warnings

Alcohol warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/ fever reducers.

Acetaminophen may cause liver damage.

Do not use with any other product containing acetaminophen

Ask a doctor before use if you have

• a sodium-restricted diet

• any liver, kidney, or heart disease

• high blood pressure

Ask a doctor or pharmacist before use if you are

• allergic or sensitive to any tablet ingredients

• pregnant, breastfeeding or may become pregnant

When using this product

• do not exceed the recommend dosage

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.

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

Directions

do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take two tablets fully dissolved in 8 oz of water every 4 to 6 hours as needed.

• do not take more than 8 tablets in 24 hours.

• do not use more than 10 days unless directed by a doctor.

Children under 12 years do not use this adult product; this will provide more than the dose (overdose) of pain reliever and may cause liver damage.

Active Ingredient

Acetaminophen 500 mg

Other Information

Each tablet contains:

Sodium 192 mg.

Store at room temperature 68 F-77 F (20oC-25oC).

Inactive Ingredients

anhydrous citric acid, dimethicone, docusate sodium, flavors, ginger oil, lemongrass oil, mannitol, polyethylene glycol 6000, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium chloride, sodium citrate, sucralose, sucrose.

Keep This and All Medication 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 immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

▪ headache

▪ backache

▪ toothache

▪ the common cold

▪ minor pain of arthritis

▪ muscular aches

▪ premenstrual and menstrual cramps

• temporarily reduces fever

Image

Purpose

Pain reliever/ Fever Reducer

Warnings

Alcohol warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/ fever reducers.

Acetaminophen may cause liver damage.

Do not use with any other product containing acetaminophen

Ask a doctor before use if you have

• a sodium-restricted diet

• any liver, kidney, or heart disease

• high blood pressure

Ask a doctor or pharmacist before use if you are

• allergic or sensitive to any tablet ingredients

• pregnant, breastfeeding or may become pregnant

When using this product

• do not exceed the recommend dosage

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.

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

Directions

do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take two tablets fully dissolved in 8 oz of water every 4 to 6 hours as needed.

• do not take more than 8 tablets in 24 hours.

• do not use more than 10 days unless directed by a doctor.

Children under 12 years do not use this adult product; this will provide more than the dose (overdose) of pain reliever and may cause liver damage.

Active Ingredient

Acetaminophen 500 mg

Other Information (Other information)

Each tablet contains:

Sodium 192 mg.

Store at room temperature 68 F-77 F (20oC-25oC).

Inactive Ingredients

anhydrous citric acid, dimethicone, docusate sodium, flavors, ginger oil, lemongrass oil, mannitol, polyethylene glycol 6000, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium chloride, sodium citrate, sucralose, sucrose.

Keep This and All Medication Out of Reach of Children. (KEEP THIS AND ALL MEDICATION 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 immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Advanced Ingredient Data


Raw Label Data

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