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

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

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.

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

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

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 or comments?

1-800-719-9260

Package/Label Principal Display Panel

See New Warnings

COMPARE TO the Active Ingredients of Extra Strength Tylenol® PM

Pain Relief PM

Pain Reliever / Nighttime Sleep Aid

Acetaminophen / Diphenhydramine HCl

Extra Strength

ACTUAL SIZE

For Adults

Non-Habit Forming

80 GELCAPS

HyVee Pain Relief PM Image 1
HyVee Pain Relief PM Image 2
PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl capsule, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-829
Route of Administration ORAL DEA Schedule     
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
Color BLUE (Dark Blue Opaque) , GRAY, BLUE (Light Blue Opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code L829
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42507-829-27 1 in 1 CARTON
1 80 in 1 BOTTLE
2 NDC:42507-829-49 1 in 1 CARTON
2 40 in 1 BOTTLE
3 NDC:42507-829-60 1 in 1 CARTON
3 20 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/02/2010
Labeler - HyVee Inc (006925671)

Revised: 2/2015
Document Id: 9e1f3a10-8544-4ff2-a220-76178ed88f5f
Set id: 0049730b-f99b-47a8-b075-8a348de11e12
Version: 3
Effective Time: 20150227
 
HyVee Inc