PAIN RELIEVER PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl capsule

Pain Reliever PM by

Drug Labeling and Warnings

Pain Reliever PM by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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
• 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 

Stop use and ask a doctor if

• sleeplessness persists continuosuly 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 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 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 between 20o- 25o C (68o- 77o F)
• avoid high humidity

Inactive ingredients

croscarmellose sodium, D&C red #28, D&C yellow #10 edible ink, FD&C blue #1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, purified water, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions or comments?

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

Principal Display Panel

Compare to the active ingredients of TYLENOL® PM*

Extra Strength

Pain Reliever PM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pain Reliever/Nighttime Sleep-Aid

Non-habit forming

Rapid Release Gelcaps

Gelcaps

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

VISIT FAMILY DOLLAR.COM

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD, MATTHEWS, NC 28105 USA

Product Label

Family Wellness Extra Strength Pain Reliever PM

INGREDIENTS AND APPEARANCE

PAIN RELIEVER PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-237
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)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	G3G3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-237-12	1 in 1 CARTON	07/31/2014
1		120 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 55319-237-03	1 in 1 BOX	07/31/2014
2		300 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 FINAL	part341	07/31/2014

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)