PAIN RELIEVER PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, film coated

Pain Reliever PM by

Drug Labeling and Warnings

Pain Reliever PM by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (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

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

• with any other product containing diphenhydramine, even one used on skin
• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• liver disease
• glaucoma
• 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

• avoid alcoholic beverages
• drowsiness will occur
• 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 caplets at bedtime. Do not take more than 2 caplets 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)
• see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

QUALITY
+PLUS

NDC: 50844-235-15

*Compare to active ingredients in
Extra Strength Tylenol® PM

EXTRA STRENGTH
Pain Reliever PM

Acetaminophen, Diphenhydramine HCl

PAIN RELIEVER/NIGHTTIME SLEEP-AID

50 Caplets

Non-habit Forming

ACTUAL
SIZE

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered
trademark Extra Strength Tylenol® PM.
50844        REV0417J23515

Distributed by
LNK International, Inc.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-235

INGREDIENTS AND APPEARANCE

PAIN RELIEVER PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-235
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-235-15	1 in 1 CARTON	05/15/1994
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/15/1994

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(50844-235)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(50844-235)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(50844-235)