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Pain Reliever PM Extra Strength

Dosage form: capsule
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Family Dollar (FAMILY WELLNESS)
NDC Code: 55319-237

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

PAIN RELIEVER PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-237
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
STARCH, CORN 
WATER 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 2 
POVIDONES 
CELLULOSE, MICROCRYSTALLINE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeG3G3
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-237-121 BOTTLE in 1 CARTON
1120 CAPSULE in 1 BOTTLE
2NDC:55319-237-031 BOTTLE in 1 BOX
2300 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/31/2014
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

 
Family Dollar (FAMILY WELLNESS)

← See all Pain Reliever PM Extra Strength brands

Medically reviewed on Aug 6, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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