ACETAMINOPHEN ORAL SOLUTION- acetaminophen oral solution solution 
Cardinal Health

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

Active Ingredient

Active ingredient (in each 5 mL cup) ‑ Purpose Acetaminophen USP 160 mg…………………………..………………..Pain reliever / fever reducer

Purpose

Pain reliever / fever reducer

Acetaminophen 160 mg / 5 mL Unit Dose Cup

Directions

Do not use more than directed Shake well before use

Age (yr)

Dose (mL)

adults

take 20 mL (640 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

Keep Out of Reach of Children

Keep out of reach of children.

Warnings and Precautions

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

Warnings

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.

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

Ask Doctor

- 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 of a serious condition

Inactive Ingredients

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

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

Generic Section

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

Distributed By:

Cardinal Health

Dublin, OH 43017

L55967620320

Principal Display Panel

Acetaminophen Oral Solution, USP

160 mg/ 5 mL

5 Cups

bag label
ACETAMINOPHEN ORAL SOLUTION 
acetaminophen oral solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-8088(NDC:0904-6738)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 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:55154-8088-55 in 1 BAG04/08/2019
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 finalpart34304/08/2019
Labeler - Cardinal Health (603638201)

Revised: 6/2020
Document Id: 661886e0-d8df-41e6-ae42-ab6f0144fa76
Set id: 661886e0-d8df-41e6-ae42-ab6f0144fa76
Version: 1
Effective Time: 20200608
 
Cardinal Health