HEALTHY ACCENTS PAIN RELIEF PM EXTRA STRENGTH - acetaminophen and diphenhydramine hydrochloride tablet, film coated
DZA Brands LLC

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 caplet)

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 caplets at bedtime
do not take more than 2 caplets 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

carnauba wax, crospovidone, FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Extra Strength Tylenol® PM active ingredients

SEE NEW WARNINGS INFORMATION

extra strength

pain relief PM

acetaminophen- diphenhydramine HCl

pain reliever

nighttime sleep aid

non-habit forming

Pain Relief PM Carton Image 1

Pain Relief PM Carton Image 2

HEALTHY ACCENTS PAIN RELIEF PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-437
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
CARNAUBA WAX
CROSPOVIDONE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	BLUE (Light blue)	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	L437;PM
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55316-437-71	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		50 TABLET, FILM COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (55316-437-71)
2	NDC:55316-437-78	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		100 TABLET, FILM COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (55316-437-78)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	01/29/2008

Labeler - DZA Brands LLC (090322194)

Revised: 05/2009 DZA Brands LLC