PERCOGESIC EXTRA STRENGTH- acetaminophen and diphenhydramine capsule, coated

Percogesic Extra Strength by

Drug Labeling and Warnings

Percogesic Extra Strength by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 12.5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Uses

For temporary relief of minor aches and pains due to:

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

Temporarily relieves

• runny nose
• sneezing
• itchy nose and throat

Warnings

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

• more than 6 tablets in 24 hours, which is the maximum daily amount
• 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
• 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

• 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 out of reach of children.

Overdose Warning

Taking more than the recommeded dose (overdose) could cause seroius 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 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 tablets every 6 hours. Maximum daily dose is 6 tablets. 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 #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

Extra Strength Percogesic, Acetaminophen / Diphenhydramine

60 coated tablets

PRINCIPAL DISPLAY PANEL

Extra Strength Percogesic, Acetaminophen / Diphenhydramine

40 coated tablets

INGREDIENTS AND APPEARANCE

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

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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

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	07/07/2010
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 63029-049-40	1 in 1 BOX	07/24/2010
2		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/07/2010

Labeler - Medtech Products Inc. (122715688)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		057795122	manufacture(63029-049)