EXTRA STRENGTH PAIN RELIEF PM - acetaminophen and diphenhydramine hydrochloride capsule, liquid filled
P and L Development of New York Corporation

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 geltab)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain Reliver

Nighttime sleep aid

Uses

for temporary relief of occasional headaches, minor aches and pains accompanying sleeplessness.

Warnings

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

more than 2 geltabs 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

Overdose warning:Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Ask a doctor before use if you have

liver disease
asthma
breathing problems such as emphysema or chronic bronchitis
glaucoma
difficulty in urinating due to an enlargement of the prostate gland

Do not use

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

Ask a doctor 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

new symptoms occur
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
sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

do not exceed recommended dose
adults and children 12 years of age and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs in 24 hours
children under 12 years of age: 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.

Other Information

store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

corn starch, DandC Red #27 aluminum lake, edible black ink, FDandC Blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate, stearic acid and titanium dioxide.

Questions or comments?

call toll free: 1-877-753-3935

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM

Compare to the active ingredients in Tylenol PM (R)
NDC 59726-360-50

SEE NEW WARNING INFORMATION

Pain Relief PM
Acetaminophen, 500mg - Diphenhydramine, HCl 25mg
Pain Reliever/Nighttime Sleep Aid
50geltabs

Product Package Label

Extra Strength Pain Relief PM

Product Carton Label

Extra Strength Pain Relief PM

EXTRA STRENGTH PAIN RELIEF PM
acetaminophen, diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59726-360(NDC:10888-7059)
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
STARCH, CORN
D&C RED NO. 27
ALUMINUM OXIDE
FD&C BLUE NO. 1
GELATIN
GLYCERIN
HYPROMELLOSES
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POVIDONE
WATER
SILICON DIOXIDE
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	blue (BLUE) , white (WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	BP50
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:59726-360-50	1 BOTTLE ( BOTTLE) in 1 BOX	contains a BOTTLE
1		50 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE	This package is contained within the BOX (59726-360-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/02/2011

Labeler - P and L Development of New York Corporation (800014821)

Revised: 09/2011 P and L Development of New York Corporation