PM GET RELIEF- acetaminophen and diphenhydramine hydrochloride tablet

PM Get Relief by

Drug Labeling and Warnings

PM Get Relief by is a Otc medication manufactured, distributed, or labeled by Eagle Distributors,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purposes
Acetaminophen 500 mg	Pain reliever
Diphenhydramine HCl 25 mg	Nighttime sleep aid

Uses

temporarily relieves 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 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
• 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 serious underlying medical illness.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts 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.

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. (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

• Adults and children 12 years of age and over: Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
• Children under 12 years of age: Do not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems

Other information

• store between20-25 C (68-77 F)
• do not use if pouch is torn or open

Inactive ingredients

croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.

Questions or comments?

Call 1-800-570-8650 (M-F 9am to 5pm PST)

SPL UNCLASSIFIED SECTION

Product manufactured for:
Eagle Distributors,Inc.
Los Angeles, CA 90011

PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

See New Warnings Information & Directions
Compare to the Active Ingredients in
Tylenol PM®*

Extra Strength
PM
Get Relief
Pain Reliever
Nighttime Sleep Air

Acetaminophen, Diphenhydramine HCI

INGREDIENTS AND APPEARANCE

PM GET RELIEF 
acetaminophen and diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68737-224
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)
hypromelloses (UNII: 3NXW29V3WO)
cellulose, microcrystalline (UNII: OP1R32D61U)
polyethylene glycols (UNII: 3WJQ0SDW1A)
povidone (UNII: FZ989GH94E)
stearic acid (UNII: 4ELV7Z65AP)
titanium dioxide (UNII: 15FIX9V2JP)
polyvinyl alcohol (UNII: 532B59J990)
silicon dioxide (UNII: ETJ7Z6XBU4)
talc (UNII: 7SEV7J4R1U)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL (Capsule shape)	Size	17mm
Flavor		Imprint Code	AZ;020
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68737-224-08	50 in 1 BOX
1		2 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/30/2012

Labeler - Eagle Distributors,Inc. (929837425)