ACETAMINOPHEN ORAL SOLUTION- acetaminophen oral solution solution 
Cardinal Health 107, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Acetaminophen USP 325 mg

Purpose

Pain reliever/ fever reducer

Keep Out of Reach of Children

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver

damage. In case of overdose, get medical help or contact Poison Control Center (1-800-222-

1222) right away. Quick medical attention is critical for adults as well as for children even if you

do not notice any signs or symptoms.

Uses

temporarily relieves minor aches and pains due to:

•
minor pain of arthritis
•
muscular aches
•
backache
•
premenstrual and menstrual cramps
•
the common cold
•
headache
•
toothache
•
temporarily reduces fever

Warnings

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

•
adults take more than 6 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 other inactive ingredients in this product.

Ask Doctor

Ask a doctor before use if this user

•
Has liver disease
•
Is pregnant or breast-feeding

Ask Doctor/Pharmacist

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

Stop Use

Stop use and ask a doctor if

•
Pain gets worse or lasts more than 10 days
•
new symptoms occur
•
fever gets worse or lasts more than 3 days
•
redness or swelling is present

These could be signs or a serious condition

Directions

•
Do not use more than directed
•
Shake well before use

Age (yr)

Dose (mL)

Adults
•
take 20.3 mL (650 mg) every 4 to 6 hours
•
not to exceed 6 doses in a 24-hour period
•
do not take more than 10 days unless directed by doctor

Under 18 years of age
•
ask a doctor

Other Information

•
store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)
•
protect from excessive moisture
•
do not use if lid seal is open or damaged
•
sugar free, dye free, alcohol free
•
see bottom of cup for lot number and expiration date

Inactive Ingredients

cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose, propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitrol, sucralose, xantham gum

Questions

Questions or comments?

Call 1-800-616-2471

Rev. 01/19

Generic Section

Distributed By:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Distributed By:

Cardinal Health

Dublin, OH 43017

L57472581221

Package/Label Principal Display Panel

Acetaminophen Oral Solution, USP

325 mg/10.15 mL

5 Cups

bag label
ACETAMINOPHEN ORAL SOLUTION 
acetaminophen oral solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-3553(NDC:0904-6739)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10.15 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorWHITE (white to light pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-3553-55 in 1 BAG12/04/201804/29/2022
110.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/04/201804/29/2022
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 1/2023
Document Id: 53aed601-51dd-4b36-b9ed-e9d9b55d741d
Set id: 21e2e700-8d5b-44ec-b517-cb812bfb5953
Version: 2
Effective Time: 20230104
 
Cardinal Health 107, LLC