Acetaminophen Oral Solution USP Alcohol Free

Acetaminophen Oral Solution USP Alcohol Free

Drug Labeling and Warnings

Drug Details

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ACETAMINOPHEN- acetaminophen 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 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 you take:

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • with other drugs containing acetaminophen
  • 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.

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are allergic to acetaminophen or any of the inactive ingredients of this product

Ask a doctor before use if you have

  • liver disease

Ask a doctor or pharmacist before use if

  • you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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 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:

Available overbagged with 5 x 20.3 mL unit dose cups per bag, NDC: 55154-9449-5

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.

MANUFACTURED BY:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Distributed By:

Cardinal Health

Dublin, OH 43017

L53336120218

R01/17

Principal Display Panel

Acetaminophen Oral Solution USP

650 mg/ 20.3 mL

5 Cups

bag label
ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55154-9449(NDC: 0121-1971)
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55154-9449-55 in 1 BAG08/01/2007
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 finalpart34308/01/2007
Labeler - Cardinal Health (603638201)

Revised: 11/2018
 
Cardinal Health


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