GOOD NEIGHBOR PHARMACY PAIN RELIEF RAPID RELEASE EXTRA STRENGTH - acetaminophen tablet, 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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Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

more than 8 gelcaps in 24 hours, which is the maximum daily amount
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 the blood thinning drug warfarin

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days

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 use more than directed (see Liver warning)

adults and children 12 years and over	take 2 gelcaps every 6 hours while symptoms last do not take more than 8 gelcaps in 24 hours do not use for more than 10 days unless directed by a doctor
children under 12 years	do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause liver damage

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® Extra Strength Rapid Release Gels active ingredient

FAST RELIEF

Pain Relief

Extra Strength

acetaminophen

pain reliever/fever reducer

500 mg each

Rapid Release

Pain Relief Carton Image 1

Pain Relief Carton Image 2

GOOD NEIGHBOR PHARMACY PAIN RELIEF RAPID RELEASE EXTRA STRENGTH
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-003
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYDROXYPROPYL CELLULOSE
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE
HYPROMELLOSES
POLYETHYLENE GLYCOLS

Product Characteristics
Color	RED (grey top)	Score	no score
Shape	CAPSULE (tablet)	Size	19mm
Flavor		Imprint Code	L046
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:46122-003-71	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		50 TABLET, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (46122-003-71)
2	NDC:46122-003-62	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		24 TABLET, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (46122-003-62)
3	NDC:46122-003-78	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
3		100 TABLET, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (46122-003-78)
4	NDC:46122-003-76	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
4		120 TABLET, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (46122-003-76)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/10/2009

Labeler - Amerisource Bergen (007914906)

Revised: 09/2011 Amerisource Bergen