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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Acetaminophen Oral Solution USP 650 mg/20.3 mL

Active ingredient

Active ingredient (in each 20.3 mL cup) Acetaminophen USP 650 mg

Purpose

Pain reliever / fever reducer

Deliver 20.3 mL

Indications and Usage

 
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
muscular aches

Instructions For Use

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 use more than 10 days unless directed by a doctor

under 18 years of age

ask a doctor

Warnings

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

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

Other Safety Information

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

Ask Doctor

 
Before use if the user:
has liver disease
is pregnant or breast-feeding ____________________________________________________________________________

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

These could be signs of a serious condition

Keep Out of Reach of Children

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.

Inactive Ingredients

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

Package/Label Principal Display Panel

Acetaminophen Oral Solution, USP

650 mg/ 20.3 mL

5 Cups

bag label
ACETAMINOPHEN ORAL SOLUTION 
acetaminophen oral solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-3360(NDC:0904-6820)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20.3 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8)  
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:55154-3360-55 in 1 BAG04/08/201904/29/2022
120.3 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 finalpart34304/08/201904/29/2022
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 12/2022
 
Cardinal Health 107, LLC