PERCOGESIC ORIGINAL STRENGTH- acetaminophen and diphenhydramine tablet, coated

Percogesic Original Strength by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Acetaminophen, 325 mg

Diphenhydramine, 12.5 mg

Purpose

Pain reliever/Fever reducer

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

Temporarily relieves:

• runny nose
• sneezing
• itchy nose and throat

Warnings

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

• adult or child 12 years and older takes more than 8 tablets in 24 hours, which is the maxiumum 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 on the skin
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor 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 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 signes or symptoms.

Do not exceed the recommended dosage.

Directions

Adults and children 12 years of age and older: take 2 tablets every 4 - 6 hours. Maximum daily doese is 8 tablets. Children under 12 years of age: aske a doctor.

Other information

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

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, stearic acid

Questions?

1-800-443-4908

PRINCIPAL DISPLAY PANEL

Percogesic Original Strength

Acetaminophen / Diphenhydramine

90 tablets

PRINCIPAL DISPLAY PANEL

Percogesic Original Strength

Acetaminophen / Diphenhydramine

50 tablets

PRINCIPAL DISPLAY PANEL

Percogesic Original Strength

Acetaminophen / Diphenhydramine

24 tablets

INGREDIENTS AND APPEARANCE

PERCOGESIC ORIGINAL STRENGTH 
acetaminophen and diphenhydramine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 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 SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	Percogesic
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-050-04	1 in 1 BOX	03/19/2010
1		90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 63029-050-50	1 in 1 BOX	03/19/2010
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 63029-050-24	1 in 1 BOX	03/19/2010
3		24 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	03/19/2010

Labeler - Medtech Products Inc. (122715688)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		057795122	manufacture(63029-050)