PERCOGESIC EXTRA STRENGTH- acetaminophen and diphenhydramine capsule, coated 
Medtech Products 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.

----------

Percogesic Extra Strength

Drug Facts

Active Ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Active Ingredient (in each caplet)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses:

for temporary relief of minor aches and pains due to:

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:

Overdose

warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. Do not exceed the recommended dosage.

Ask a doctor before use

if the user has liver disease.

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.

Do not use

with any other product containing diphenhydramine, even one used on skin.

Ask a doctor or pharmacist before use

  • if the user is taking the blood thinning drug warfarin.

Ask a doctor or pharmacist before use

if you are taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may cause drowsiness
  • may cause excitability, especially in children
  • be careful driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

  • pain persists for more than 10 days
  • fever persists for more than 3 days (unless directed by a doctor)
  • condition worsens or new symptoms occur
  • redness or swelling is present.

These may be signs of a serious condition.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

Keep this and all drugs out of the reach of children.

Directions

Adults and children 12 years of age and older: take 2 caplets every 6 hours. Maximum daily dose is 8 caplets. Children under 12 years of age: do not use this product in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

Inactive Ingredients

FD&C Yellow #6 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinylpyrrolidone, Polyvinyl alcohol, Silicon Dioxide, Sodium Carboxymethyl Starch, Starch, Stearic Acid, Talc, Titanium Dioxide

Questions?

1-800-443-4908

©2010 Distributed by Medtech Products Inc.

Irvington, NY 10533, a Prestige Brands Company

Visit us at www.percogesic.com

PRINCIPAL DISPLAY PANEL

FAST ACTING EXTRA STRENGTH
Percogesic
®
Acetaminophen/

Diphenhydramine

for ENCHANCED

RELIEF of PAIN

Aspirin-Free, Pain Reliever,

Fever Reducer/ Antihistamine

See new warnings information.

60 EASY TO SWALLOW COATED TABLETS

PRINCIPAL DISPLAY PANEL
Fast Acting Extra Strength Percogesic 
60 tablets

PERCOGESIC EXTRA STRENGTH 
acetaminophen and diphenhydramine capsule, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-049
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 (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code ESP
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63029-049-13 1 in 1 BOX
1 60 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/07/2010
Labeler - Medtech Products Inc. (122715688)
Establishment
Name Address ID/FEI Business Operations
Avema Pharma Solutions 804087794 MANUFACTURE

Revised: 7/2010
Document Id: 76c1a847-0e19-40ad-9a85-ae53f0c5322f
Set id: 7a07713f-98c4-4e32-bb7a-89155f14b07f
Version: 5
Effective Time: 20100724
 
Medtech Products Inc.