Aerotab Non-aspirin Tablets

Aerotab Non-aspirin Tablets
SPL v2
SPL
SPL Set ID faa3a4ef-3c70-06ca-e053-6394a90a512d
Route
ORAL
Published
Effective Date 2023-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Povidone Stearic Acid Starch, Corn Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 12 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-31

Description

Acteminophen 500 mg


Medication Information

Warnings and Precautions

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4000 mg of acetaminophen in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy Warning: 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.

Description

Acteminophen 500 mg

Uses

temporary relief of minor aches and pains associated with

  • common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • menstrual cramps
  • temporarily reduces fever
Section 50565-1

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs
Section 50568-5

Ask a 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 50570-1

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Section 53414-9

If pregnant or breast-feeding

ask a health professional before use.

Section 55105-1

Pain reliever / fever reducer

Section 55106-9

Acteminophen 500 mg

Directions
  • take only as directed - see Overdose warning
  • do not take more than 8 tablets in any 24 hour period
  • do not use more than 10 days unless directed to do so by a doctor

Adults and children 12 years and over: take 2 tablets every 4 to 6 hours.

Children under 12 years of age: do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

Tamper evident. Do not use if packet is torn, cut or opened. Store between 20°-25°C (68°-77°F). Read all warnings and directions before use.

Non Aspirin Tablet

AEROTAB

Non-Aspirin

acetaminophen 500mg

Fever reducer

Pain Reliever

Relieves aches

2 per packet

Inactive Ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid


Structured Label Content

Uses (USES)

temporary relief of minor aches and pains associated with

  • common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • menstrual cramps
  • temporarily reduces fever
Warnings and Precautions (34071-1)

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4000 mg of acetaminophen in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy Warning: 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.

Section 50565-1 (50565-1)

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs
Section 50568-5 (50568-5)

Ask a 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 50570-1 (50570-1)

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Section 53414-9 (53414-9)

If pregnant or breast-feeding

ask a health professional before use.

Section 55105-1 (55105-1)

Pain reliever / fever reducer

Section 55106-9 (55106-9)

Acteminophen 500 mg

Directions (DIRECTIONS)
  • take only as directed - see Overdose warning
  • do not take more than 8 tablets in any 24 hour period
  • do not use more than 10 days unless directed to do so by a doctor

Adults and children 12 years and over: take 2 tablets every 4 to 6 hours.

Children under 12 years of age: do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information (OTHER INFORMATION)

Tamper evident. Do not use if packet is torn, cut or opened. Store between 20°-25°C (68°-77°F). Read all warnings and directions before use.

Non Aspirin Tablet

AEROTAB

Non-Aspirin

acetaminophen 500mg

Fever reducer

Pain Reliever

Relieves aches

2 per packet

Inactive Ingredients (INACTIVE INGREDIENTS)

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)