Adwe Feverx Acetaminophen Caplets, 500 mg

Drug Details [pdf]

ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH- acetaminophen tablet
Aurex Laboratories Limited Liability Company

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Adwe Feverx Acetaminophen Caplets, 500 mg

Active Ingredient: Acetaminophen 500 mg

Uses:

temporarily relives minor aches and pains
temporarily reduces fever

Minor aches and pains, fever.

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.

Ask a doctor before use if you have liver disease.

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

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.

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.

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

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

Other information

Store at 20° C - 25° C (68° F - 77° F)

Inactive ingredients:

microcrystalline cellulose, vegetable magnesium stearate. May contain povidone.

* 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

ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71009-109
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	A;A2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 71009-109-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	03/09/2021	01/01/2025

Labeler - Aurex Laboratories Limited Liability Company (067585317)

Registrant - Adwe Products & Imports Inc. (080081765)

Name	Address	ID/FEI	Business Operations
Establishment
Aurex Laboratories Limited Liability Company		067585317	manufacture(71009-109)

Revised: 12/2024

Document Id: 29f3529d-efd6-6c30-e063-6294a90ad778

Set id: 948c5826-6f35-484d-bb3f-cecf6a4b5c13

Version: 5

Effective Time: 20241223

Aure

Adwe Feverx Acetaminophen Caplets, 500 mg

Adwe Feverx Acetaminophen Caplets, 500 mg by

Drug Labeling and Warnings

Drug Details [pdf]

Adwe Feverx Acetaminophen Caplets, 500 mg

Warnings

Do not use