Extra Strength Acetaminophen by Preferred Pharmaceuticals, Inc. gc204

Extra Strength Acetaminophen by

Drug Labeling and Warnings

Extra Strength Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet 
Preferred Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

gc204

Active Ingredients

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. The
maximum daily dose of this product is 6 tablets in 24 hours.
Severe liver damage may occur if you take:

• more than 8 tablets (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 are

taking 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 symptom 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. 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.

Directions

• do not take more than directed
• adults and 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, unless directed by a doctor.
• 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 20⁰C-25⁰C (68⁰F-77⁰F)
•   Bottle of 20 NDC: 68788-7743-02
  Bottle of 30 NDC: 68788-7743-03
  Bottle of 45 NDC: 68788-7743-04
  Bottle of 50 NDC: 68788-7743-05
  Bottle of 60 NDC: 68788-7743-06
  Bottle of 100 NDC: 68788-7743-01

Inactive Ingredients

povidone, sodium starch glycolate, starch, stearic acid.

EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-7743(NDC: 57896-204)
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
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	ROUND (Round)	Size	12mm
Flavor		Imprint Code	AZ011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-7743-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	09/06/2022
2	NDC: 68788-7743-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	09/06/2022
3	NDC: 68788-7743-4	45 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	09/06/2022
4	NDC: 68788-7743-5	50 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	09/06/2022
5	NDC: 68788-7743-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	09/06/2022
6	NDC: 68788-7743-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	09/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/01/2020	09/06/2022

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc.		791119022	REPACK(68788-7743)

Revised: 9/2022

Document Id: b15db073-24cf-4236-948a-f176264af4ce

34390-5

Set id: 03b7e66e-4b24-4fb0-a198-0f68904c1f3f

Version: 3

Effective Time: 20220906