ADDED STRENGTH PM - acetaminophen and diphenhydramine hydrochloride tablet, film coated
Western Family Foods 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.

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Active ingredients (in each tablet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

(equiv. to Diphenhydramine citrate 38 mg)

Purposes

Pain reliever

Nighttime sleep-aid

Uses

for the 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

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
in children under 12 years of age
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
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

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 may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating 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 for more than 10 days
fever gets worse or lasts for 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 use more than directed (see Liver warning)

Adults and children 12 years of age and over:

take 2 tablets at bedtime, if needed, or as directed by a doctor
do not take more than 2 tablets of this product in 24 hours

Children under 12 years of age:

do not use

Other information

store at 20°-25°C (68°-77°F)

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

Principal Display Panel

SEE NEW WARNINGS INFORMATION

Aspirin Free

Added Strength PM

PAIN RELIEVER plus NIGHTTIME SLEEP AID

ACETAMINOPHEN/DIPHENHYDRAMINE HCl

Gluten Free

COMPARE TO EXCEDRIN® PM active ingredients

Added Strength PM Carton Image 1

Added Strength PM Carton Image 2

ADDED STRENGTH PM
acetaminophen, diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-355
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 GLYCOLS
POLYSORBATE 80
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND (shallow convex)	Size	11mm
Flavor		Imprint Code	L355;PM
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55312-355-71	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 (55312-355-71)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	11/25/1997

Labeler - Western Family Foods Inc (192166072)

Revised: 04/2010 Western Family Foods Inc