Adwe Feverx Acetaminophen Caplets, 500 Mg

Adwe Feverx Acetaminophen Caplets, 500 Mg
SPL v6
SPL
SPL Set ID 948c5826-6f35-484d-bb3f-cecf6a4b5c13
Route
ORAL
Published
Effective Date 2021-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Microcrystalline Cellulose Magnesium Stearate Povidone

Identifiers & Packaging

Pill Appearance
Imprint: A;A2 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-09

Description

Active Ingredient: Acetaminophen 500 mg


Medication Information

Indications and Usage

Minor aches and pains, fever.

Dosage and Administration

Directions:

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 caplets every 4-6 hours, as needed. Do not take more than 6 caplets in 24 hours, unless directed by a doctor.
  • children under 12 years: ask a doctor
Dosage Forms and Strengths

* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL ®.

Distributed By:

Adwe Laboratories

1274 49 St. Brooklyn, NY 11219

This product contains no animal, soybean, or grain derivatives.

This product does not contain any Chometx or Krtnius.

REV 0221

Description

Active Ingredient: Acetaminophen 500 mg

Section 44425-7

Other information

  • Store at 20° C - 25° C (68° F - 77° F)
Section 50565-1

Keep out of reach of children. 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.

Section 50567-7

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.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you have liver disease.

Section 51727-6

Inactive ingredients:

microcrystalline cellulose, vegetable magnesium stearate. May contain povidone.

Section 51945-4
Section 53414-9

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

Section 55105-1

Uses:

  • temporarily relives minor aches and pains
  • temporarily reduces fever
Section 55106-9

Active Ingredient: Acetaminophen 500 mg

Warnings

Liver warninig:This product contains acetaminophen. The maximum daily dose of this product is 6 caplets in 24 hours. Severe liver damage may occur if you take:

  • more than 8 caplets (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.

Structured Label Content

Indications and Usage (34067-9)

Minor aches and pains, fever.

Dosage and Administration (34068-7)

Directions:

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 caplets every 4-6 hours, as needed. Do not take more than 6 caplets in 24 hours, unless directed by a doctor.
  • children under 12 years: ask a doctor
Dosage Forms and Strengths (34069-5)

* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL ®.

Distributed By:

Adwe Laboratories

1274 49 St. Brooklyn, NY 11219

This product contains no animal, soybean, or grain derivatives.

This product does not contain any Chometx or Krtnius.

REV 0221

Section 44425-7 (44425-7)

Other information

  • Store at 20° C - 25° C (68° F - 77° F)
Section 50565-1 (50565-1)

Keep out of reach of children. 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.

Section 50567-7 (50567-7)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease.

Section 51727-6 (51727-6)

Inactive ingredients:

microcrystalline cellulose, vegetable magnesium stearate. May contain povidone.

Section 51945-4 (51945-4)
Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses:

  • temporarily relives minor aches and pains
  • temporarily reduces fever
Section 55106-9 (55106-9)

Active Ingredient: Acetaminophen 500 mg

Warnings

Liver warninig:This product contains acetaminophen. The maximum daily dose of this product is 6 caplets in 24 hours. Severe liver damage may occur if you take:

  • more than 8 caplets (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 (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.

Advanced Ingredient Data


Raw Label Data

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