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

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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:

  • headache
  • backache
  • muscular aches
  • arthritis pain
  • colds
  • flu
  • fever
  • toothache
  • premenstrual and menstrual cramps

Warnings

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

  • adult or child 12 years and older takes more than 8 caplets in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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
  • 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 your 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 professional before use.

Keep this and all drugs 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.

Do not exceed recommended dosage.

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: ask a doctor.

Other information

  • store at 15°-30°C (59°-86°F)
  • avoid excessive heat

Inactive ingredients

croscarmellose sodium, FD&C yellow no. 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide, triacetin

Questions?

1-800-443-4908

PRINCIPAL DISPLAY PANEL

FAST ACTING EXTRA STRENGTH
Percogesic
®
Acetaminophen/

Diphenhydramine

for ENCHANCED

RELIEF of PAIN

Aspirin-Free, Pain Reliever,

Fever Reducer/ Antihistamine


40 EASY TO SWALLOW COATED TABLETS

PRINCIPAL DISPLAY PANEL
FAST ACTING EXTRA STRENGTH
Percogesic®
Acetaminophen/
Diphenhydramine
for ENCHANCED
RELIEF of PAIN
Aspirin-Free, Pain Reliever,
Fever Reducer/ Antihistamine

40 EASY TO SWALLOW COATED TABLETS

PERCOGESIC EXTRA STRENGTH 
acetaminophen and diphenhydramine capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-049
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE12.5 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code ESP
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-049-131 in 1 BOX07/07/201003/15/2024
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:63029-049-141 in 1 BOX07/07/201003/15/2024
240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/07/201003/15/2024
Labeler - Medtech Products Inc. (122715688)

Revised: 3/2024
 
Medtech Products Inc.