Pain Reliever Pm Extra Strength (Acetaminophen, Diphenhydramine Hcl) Tablet [Walgreen Company] -

PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [WALGREEN COMPANY]
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NDC	0363-0556-09, 0363-0556-31, 0363-0556-54, 0363-0556-57
Set ID	b4d8860b-d72f-4789-945e-1c6420a8efab
Category	HUMAN OTC DRUG LABEL
Packager	Walgreen Company
Generic Name
Product Class
Product Number
Application Number	PART343

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Active ingredients (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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- 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
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- liver disease
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
- 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
Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- use by expiration date on package
Inactive ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide
Questions or comments?

1-800-426-9391
Principal Display Panel

Walgreens

Compare to Extra Strength Tylenol® PM active ingredients††

NDC 0363-0556-57

EASY OPEN

Pain Reliever PM
ACETAMINOPHEN 500 mg / PAIN RELIEVER
DIPHENHYDRAMINE HCl 25 mg /
NIGHTTIME SLEEP AID

NIGHTTIME EXTRA STRENGTH

125 GELCAPS
FAST-RELEASE QUICK GELS™

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol® PM.

50844 REV0417A55657

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED walgreens.com ©2018 Walgreen Co.

Walgreens 44-556

INGREDIENTS AND APPEARANCE

PAIN RELIEVER PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0556
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
AMMONIA (UNII: 5138Q19F1X)

Product Characteristics
Color	blue (dark blue) , blue (light blue)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	L;6
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0556-09	1 in 1 CARTON	12/17/2007
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0363-0556-31	1 in 1 CARTON	12/17/2007	02/27/2022
2		80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:0363-0556-54	375 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2007
4	NDC:0363-0556-57	125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2007