Your browser does not support JavaScript! ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH]
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ACETAMINOPHEN ORAL SOLUTION (acetaminophen) liquid
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

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

agedose
adults and children 12 years of age and over20.3 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 age10.15 mL (325 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age7.5 mL (240 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age5 mL (160 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children under 2 years of ageconsult 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

bag label
ACETAMINOPHEN ORAL SOLUTION 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55154-9417(NDC:0121-0657)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 10.15 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-9417-55 in 1 BAG
110.15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/02/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-9417)

Revised: 5/2013
 
Cardinal Health

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