GOOD NEIGHBOR PHARMACY PAIN RELIEF PM - acetaminophen and diphenhydramine hydrochloride capsule, 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

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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

Do not use

in children under 12 years of age
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on skin
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product

drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

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. (1-800-222-1222) 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 Liver warning)

Adults and Children 12 years and over:

take 2 gelcaps at bedtime
do not take more than 2 gelcaps of this product in 24 hours

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 may cause liver damage

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red no. 28, D&C yellow no. 10, edible ink, FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C yellow no. 6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

See New Warnings Information

COMPARE TO ACTIVE INGREDIENTS IN EXTRA STRENGTH TYLENOL® PM

EXTRA STRENGTH

PAIN RELIEF PM

RAPID RELEASE

ACETAMINOPHEN, DIPHENHYDRAMINE HCl

ACTUAL SIZE

Pain Reliever / Nighttime Sleep Aid

Pain Relief PM Carton Image 1

Pain Relief PM Carton Image 2

GOOD NEIGHBOR PHARMACY PAIN RELIEF PM
acetaminophen, diphenhydramine hcl capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-026
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN

Product Characteristics
Color	BLUE (Dark Blue Opaque) , GRAY, BLUE (Light Blue Opaque)	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	L829
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:46122-026-58	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		40 CAPSULE, COATED ( CAPSULE) in 1 BOTTLE	This package is contained within the CARTON (46122-026-58)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	09/08/1995

Labeler - Amerisource Bergen (007914906)

Revised: 11/2010 Amerisource Bergen