PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride capsule, coated 
HyVee Inc

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.

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Hy-Vee, Inc. Pain Relief PM Drug Facts

Active ingredient (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

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.

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 Liver 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients

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

Questions?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Extra Strength Tylenol® PM active ingredients

PAIN RELIEF PM

EXTRA STRENGTH

Pain Reliever

Night Time Sleep-Aid

Acetaminophen/Diphenhydramine HCl

Actual Size

Rapid Release

Pain Relief PM Carton Image 1
Pain Relief PM Carton Image 2
PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl capsule, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42507-829
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
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 28 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
GELATIN 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUE (Dark Blue Opaque) , GRAY, BLUE (Light Blue Opaque) Scoreno score
ShapeCAPSULESize22mm
FlavorImprint Code L829
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-829-271 in 1 CARTON
180 in 1 BOTTLE
2NDC:42507-829-491 in 1 CARTON
240 in 1 BOTTLE
3NDC:42507-829-601 in 1 CARTON
320 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33808/02/2010
Labeler - HyVee Inc (006925671)

Revised: 2/2013
Document Id: cd3487af-ea75-49e4-8e36-ecbc0d270531
Set id: 0049730b-f99b-47a8-b075-8a348de11e12
Version: 2
Effective Time: 20130207
 
HyVee Inc