PAIN RELIEVER PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet

pain reliever pm by

Drug Labeling and Warnings

pain reliever pm by is a Otc medication manufactured, distributed, or labeled by McKesson (Sunmark). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

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

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

Ask a doctor before use if you have

• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma

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 drinks
• 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 for more than 10 days
• fever gets worse or lasts for 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

Overdose warning: 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 overdose 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

Other information

• store at room temperature 15°-30°C (59°-86°F)
• avoid high humidity and excessive heat

Inactive ingredients

croscarmellose sodium*, D and C Yellow #10 Aluminum Lake*, FD and C Blue #1 Aluminum Lake, FD and C Blue #2 Aluminum Lake*, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, titanium dioxide, triacetin*

*contains one or more of these ingredients

Questions or Comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to EXTRA STRENTH Tylenol® PM active ingredients **

Pain Reliever PM

Extra Strength

Pain reliever /nighttime Sleep-Aid

Non- habit forming

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Pain Reliever PM caplets

INGREDIENTS AND APPEARANCE

PAIN RELIEVER PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-236
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	S525;CPC752
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-236-10	1 in 1 BOX	03/26/2013	12/31/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49348-236-09	1 in 1 BOX	03/26/2013	12/31/2020
2		50 in 1 BOTTLE; 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	03/26/2013	12/31/2020

Labeler - McKesson (Sunmark) (177667227)