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.

----------

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

  • in children under 12 years of age
  • 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
  • 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
  • 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

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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 lasts 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 no. 28, D&C yellow no. 10, edible ink, FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C yellow no. 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 Information

Compare to Extra Strength Tylenol® PM active ingredients

Pain Relief PM

Extra Strength

Rapid Release

Pain Reliever

Night Time Sleep Aid

Acetaminophen/Diphenhydramine HCl

Pain Relief PM Carton Image 1

Pain Relief PM Carton Image 1

Pain Relief PM Carton Image 2

Pain Relief PM Carton 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 (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
D&C RED NO. 28  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
GELATIN  
HYDROXYPROPYL CELLULOSE  
HYPROMELLOSES  
CELLULOSE, MICROCRYSTALLINE  
POVIDONE  
STEARIC ACID  
TITANIUM DIOXIDE  
TRIACETIN  
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
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 final part338 02/22/1996
Labeler - HyVee Inc (006925671)

Revised: 11/2010
HyVee Inc