Label: ACETAMINOPHEN ORAL SOLUTION- acetaminophen liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 5 mL teaspoonful)

    Acetaminophen 160 mg

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  • Purpose

    Pain reliever/fever reducer

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  • 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

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  • 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.

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  • Directions

    age dose
    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
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  • 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).
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  • Inactive ingredients

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

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  • Questions or comments?

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

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  • SPL UNCLASSIFIED SECTION

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

    Repackaged by Cardinal Health

    Zanesville, OH 43701

    R04/10

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  • PRINCIPAL DISPLAY PANEL

    ACETAMINOPHEN ORAL SOLUTION USP

    325 mg/ 10.15 mL

    5 - 10.15 mL CUPS

    bag label
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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN ORAL SOLUTION 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-9417(NDC:0121-0657)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg  in 10.15 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    FD&C RED NO. 40  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SODIUM CITRATE  
    SORBITOL  
    SUCROSE  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-9417-5 5 in 1 BAG
    1 10.15 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/02/2011
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-9417)
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