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Acetaminophen Oral Solution by Cardinal Health

Dosage form: solution
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Cardinal Health
NDC Code: 55154-9417

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.

Acetaminophen
Oral Solution USP
Alcohol Free

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

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

temporarily reduces fever

Warnings

Liver warning

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

adult takes more than 6 doses in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
adult has 3 or more alcoholic drinks everyday while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 of this product

Ask a doctor before use if the user has liver disease.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if
pain gets worse or lasts more than 10 days in adults and children
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

Taking more than the recommended dose (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.

Directions
do not take more than directed (see overdose warning)
agedose

adults and children 12 years of age and over

20.3 mL (650 mg) every 4 to 6 hours
not to exceed 6 doses in a 24-hour period

children 6 to under 12 years of age

10.15 mL (325 mg) every 4 hours
not to exceed 5 doses in a 24-hour period

children 4 to under 6 years of age

7.5 mL (240 mg) every 4 hours
not to exceed 5 doses in a 24-hour period

children 2 to under 4 years of age

5 mL (160 mg) every 4 hours
not to exceed 5 doses in a 24-hour period

children under 2 years of age

consult a doctor

Other information
sodium content: 2 mg/5 mL
store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]
keep tightly closed
protect from light
a red, cherry flavored solution supplied in the following oral dosage forms:
NDC 0121-0657-05 (unit dose cups of 5 mL, 10 × 10's), NDC 0121-0657-11 (unit dose cups of 10.15 mL, 10 × 10's), and NDC 0121-0657-21 (unit dose cups of 20.3 mL, 10 × 10's).

Inactive ingredients

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions or comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

Repackaged by Cardinal Health

Zanesville, OH 43701

R04/10

PRINCIPAL DISPLAY PANEL

ACETAMINOPHEN ORAL SOLUTION USP

325 mg/ 10.15 mL

5 - 10.15 mL CUPS

ACETAMINOPHEN ORAL SOLUTION 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9417(NDC:0121-0657)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
SORBITOL 
SUCROSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-9417-55 CUP, UNIT-DOSE in 1 BAG
110.15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/02/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-9417)

Revised: 01/2018
 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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