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Pain Relief Pain Relief PM

Medically reviewed on June 4, 2018

Dosage form: kit
Ingredients: ACETAMINOPHEN 500mg; ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Meijer Distribution Inc
NDC Code: 41250-803

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.

Meijer Distribution, Inc. Pain Relief Pain Relief PM Drug Facts

Active ingredient (in each caplet) – Pain Relief

Acetaminophen 500 mg

Active ingredients (in each caplet) – Pain Relief PM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose – Pain Relief

Pain reliever/fever reducer

Purpose – Pain Relief PM

Pain reliever

Nighttime sleep-aid

Uses – Pain Relief
temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Uses – Pain Relief PM

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings – Pain Relief

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.

Warnings – Pain Relief PM

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 – Pain Relief
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

Do not use – Pain Relief PM
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 – Pain Relief

liver disease

Ask a doctor before use if you have – Pain Relief PM
liver disease
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are – Pain Relief

taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are – Pain Relief PM
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product – Pain Relief PM
drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if – Pain Relief
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

Stop use and ask a doctor if – Pain Relief PM
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: 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 – Pain Relief
do not take more than directed (see overdose warning)

Adults and children 12 years and over:

take 2 caplets every 6 hours while symptoms last
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

Children under 12 years: ask a doctor

Directions – Pain Relief PM
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 20-25°C (68-77°F)

Inactive ingredients – Pain Relief

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Inactive ingredients – Pain Relief PM

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel – Pain Relief

VALUE 2 PACK

Compare to Extra Strength Tylenol® active ingredient

Caplets

SEE NEW WARNINGS

Pain Relief

Acetaminophen

Pain Reliever/Fever Reducer

For Adults

Extra Strength

100 CAPLETS – 500 mg EACH

Actual Size

DAY AND NIGHT RELIEF

Principal Display Panel – Pain Relief PM

VALUE 2 PACK

DAY AND NIGHT RELIEF

Compare to Extra Strength Tylenol® PM active ingredients

Extra Strength

SEE NEW WARNINGS

Pain Relief PM

Acetaminophen – Diphenhydramine HCl

Pain Reliever/Nighttime Sleep Aid

For Adults

100 CAPLETS

Actual Size

PAIN RELIEF PAIN RELIEF PM 
acetaminophen, diphenhydramine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-803
Packaging
#Item CodePackage Description
1NDC:41250-803-091 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 100 
Part 21 BOTTLE 100 
Part 1 of 2
PAIN RELIEF 
acetaminophen tablet
Product Information
Item Code (Source)NDC:41250-484
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POVIDONES 
STEARIC ACID 
CROSCARMELLOSE SODIUM 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size16mm
FlavorImprint CodeL484
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-484-781 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/15/1987
Part 2 of 2
PAIN RELIEF PM 
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Item Code (Source)NDC:41250-751
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
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeL751
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-751-781 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/22/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/06/2013
Labeler - Meijer Distribution Inc (006959555)

 
Meijer Distribution Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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