PERCOGESIC ORIGINAL STRENGTH- acetaminophen and diphenhydramine hcl tablet, coated 
Medtech Products Inc.

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Percogesic Original 63029-053

Drug Facts

Active Ingredients (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Active Ingredients (in each tablet)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

for temporary relief of minor aches and pains due to:

Temporarily relieves

Warnings

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

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor or pharmacist 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

  • 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.

If you are pregnant or breast-feeding, ask a health care professional before use.

Keep out of the reach of children.

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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dosage. Adults and children 12 years and older: take 2 tablets every 4-6 hours. Maximum daily dose is 8 tablets.

Children under 12 years of age:  ask a doctor

Other Information  

Inactive Ingredients

Croscarmellose Sodium, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Pregelatinized Starch, Silica, Sodium Starch Glycolate and Stearic Acid

Questions?

1-800-443-4908

PRINCIPAL DISPLAY PANEL

ORIGINAL STRENGTH
Percogesic®
Acetaminophen/Diphenhydramine
HCl

Aspirin-Free, Pain Reliever,

Fever Reducer/ Antihistamine


50 COATED TABLETS

PRINCIPAL DISPLAY PANEL
FAST ACTING ORIGINAL STRENGTH
Percogesic®
Acetaminophen/Diphenhydramine
for ENCHANCED
RELIEF of PAIN
Aspirin-Free, Pain Reliever,
Fever Reducer/ Antihistamine
See new warnings information.
90 EASY TO SWALLOW COATED TABLETS

PERCOGESIC  ORIGINAL STRENGTH
acetaminophen and diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-053
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TALC (UNII: 7SEV7J4R1U)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint Code Percogesic
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-053-901 in 1 BOX03/19/2010
190 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:63029-053-501 in 1 BOX03/19/2010
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:63029-053-241 in 1 BOX03/19/2010
324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/19/2010
Labeler - Medtech Products Inc. (122715688)

Revised: 3/2024
Document Id: 5bddcd0b-030e-425a-a461-aae25ff76624
Set id: 529974c2-0121-4892-8e47-c2c447581091
Version: 1
Effective Time: 20240308
 
Medtech Products Inc.