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

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Percogesic Original

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:

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 tablets 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

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.

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 and older: take 1 or 2 tablets every 4 hours. Maximum daily dose is 8 tablets.

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

store at controlled room temperature 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 and Stearic Acid

Questions?

1-800-443-4908

Keep outer carton for complete product information. © 2009 Dist. by
Medtech Products Inc., Irvington, NY 10533 A Prestige Brands Company

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

PRINCIPAL DISPLAY PANEL
Fast Acting Original Strength Percogesic
90 tablets

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63029-050-04	1 in 1 BOX	03/19/2010	03/30/2024
1		90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:63029-050-50	1 in 1 BOX	03/19/2010	03/30/2024
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:63029-050-24	1 in 1 BOX	03/19/2010	03/30/2024
3		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	03/19/2010	03/30/2024

Labeler - Medtech Products Inc. (122715688)

Revised: 3/2024

Document Id: 42bd7520-3523-4977-a994-fb85aaf214aa

Set id: 85f0a6c8-30c8-4a1f-ac35-542c77a6522a

Version: 10

Effective Time: 20240315

Medtech Products Inc.