ACETAMINOPHEN- acetaminophen tablet 
Cardinal Health 107, LLC

----------

Acetaminophen 325 mg

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

headache 
muscular aches 
backache 
minor pain of arthritis
common cold 
toothache 
premenstrual and menstrual cramps

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses 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.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults 
pain gets worse or lasts more than 5 days in children under 12 years
fever gets worse or lasts more than 3 days
new symptoms occur 
redness or swelling is present

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. This Unit Dose package is not child

resistant and is Intended for Institutional Use Only.

Directions

do not take more than directed (see overdose warning)
adults and children 12 years and over:
take 2 tablets every 4 to 6 hours while symptoms last
do not take more than 10 tablets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
take 1 tablet every 4 to 6 hours while symptoms last
do not take more than 5 tablets in 24 hours
do not use for more than 5 days unless directed by a doctor
children under 12 years: ask a doctor

Other information

store at room temperature

Inactive Ingredients: Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

(800) 616-2471

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Distributed By: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

Distributed By:

Cardinal Health

Dublin, OH 43017

L5509849-10124

L5509849-20124

Principal Display Panel

Acetaminophen

Regular Strength Tablets 325 mg

10 Tablets

Bag Label
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-7899(NDC:0904-6773)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code CPC;220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-7899-01 in 1 BAG10/23/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/23/2018
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 1/2024
Document Id: d6be94df-f49e-4b9e-8449-9da079f758ad
Set id: ee50c5ee-1a61-4efc-aca9-42d897d6a3b8
Version: 5
Effective Time: 20240108
 
Cardinal Health 107, LLC