ADWE FEVERX- acetaminophen tablet

Adwe Feverx by

Drug Labeling and Warnings

Adwe Feverx by is a Otc medication manufactured, distributed, or labeled by Syntho Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

• temporarily relieves minor aches and pains
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg (8 tablets) in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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 are

taking 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.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

Overdose Warning

Taking more than therecommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact Poison Control Centre right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see overdose warning)

adults & children 12 years and over:

• take 1-2 tablets every 4-6 hours as needed
• do not take more than 6 tablets in 24 hours

children under 12 years: do not use

Other information

​TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

• store at 20ºC - 25ºC (68ºF - 77ºF)

Inactive ingredients

povidone. May also contain: cellulose, croscarmellose sodium, magnesium silicate, silica, vegetable magnesium starate

Questions or comments

SPL UNCLASSIFIED SECTION

* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®. This products contain no animal, soybean or grain derivatives. THis product does not contains any Chometz or Kitnius.

​KOSHER FOR PASSOVER

DIST BY: Adwe Laboratories

1274 49 St. Brooklyn, NY 11219

REV 201-0415

​PRINCIPAL DISPLAY PANEL

NDC: 666576-200-01

KOSHER FOR PASSOVER

Adwe Feverx

Acetaminophen Tablets

PAIN RELIEVER FEVER REDUCER

EXTRA STRENGTH TABLETS

Compare to Active Ingredient in Extra Strength Tylenol®*

100 TABLETS 500 mg each

INGREDIENTS AND APPEARANCE

ADWE FEVERX 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66576-200
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	10mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66576-200-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/04/2020

Labeler - Syntho Pharmaceuticals, Inc. (088797407)

Registrant - Syntho Pharmaceuticals, Inc. (088797407)

Establishment
Name	Address	ID/FEI	Business Operations
Syntho Pharmaceuticals, Inc.		088797407	manufacture(66576-200)