Good Neighbor Pharmacy 44-531C Delisted

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen tablet, film coated 
Amerisource Bergen

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.

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Good Neighbor Pharmacy 44-531C Delisted

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • muscular aches
  • the common cold
  • backache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

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

• more than 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:

• blisters
• rash
• skin reddening

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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 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.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide
*may contain this ingredient

Questions or comments?

1-800-426-9391

Principal display panel

GOOD
NEIGHBOR
PHARMACY®

Compare to Extra Strength Tylenol® active ingredient†

NDC: 46122-649-71

EXTRA STRENGTH
Acetaminophen

Pain Reliever / Fever Reducer

50 Coated Tablets | 500 mg Each

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

SATISFACTION GUARANTEED
GOOD NEIGHBOR PHARMACY
BRAND PRODUCTS

Distributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com

†This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Extra Strength Tylenol®.
50844   REV1220A53115

Good Neighbor Pharmacy 44-531C

ACETAMINOPHEN 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-649
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)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;531
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-649-71	1 in 1 CARTON	07/30/2020	12/13/2023
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/30/2020	12/13/2023

Labeler - Amerisource Bergen (007914906)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(46122-649)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(46122-649)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	pack(46122-649)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(46122-649)

Revised: 3/2023

Document Id: 88e273c5-52c0-485e-a6f7-296401e00caf

34390-5

Set id: 7a110e42-e545-496e-af65-efbbb6e6ff6e

Version: 5

Effective Time: 20230307