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Acetaminophen (Pharmaceutical Associates, Inc.)

Available Formats

Dosage Form Package Information Links
SOLUTION 10 TRAY in 1 CASE (0121-0657-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10.15 mL in 1 CUP, UNIT-DOSE Label Information
SOLUTION 10 TRAY in 1 CASE (0121-0657-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20.3 mL in 1 CUP, UNIT-DOSE Label Information
SOLUTION 10 TRAY in 1 CASE (0121-0657-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE Label Information

Complete Acetaminophen Information

  • SPL UNCLASSIFIED SECTION

    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

    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


  • Other information

    â–  sodium content: 2 mg/5 mL 

    â–  store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]

    â–  keep tightly closed  â–  protect from light

    â–  a red, cherry flavored solution supplied in the following oral dosage forms:

    NDC 0121-0657-05:  5 mL unit dose cup

    NDC 0121-0657-00:   Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each.

    NDC 0121-1314-11:  10.15 mL unit dose cup

    NDC 0121-1314-00:   Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.

    NDC 0121-1971-21:  20.3 mL unit dose cup

    NDC 0121-1971-00:   Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.


  • 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

    www.paipharma.com

    R01/17


  • PRINCIPAL DISPLAY PANEL - 20 mL Cup

    Delivers 20.3 mL

    NDC 0121-1971-21

    A CETAMINOPHEN

    O RAL S OLUTION USP

    650 mg/20.3 mL

    ALCOHOL FREE

    FOR INSTITUTIONAL USE ONLY

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    F06572102

    20 mL Unit Dose Cup Label


  • PRINCIPAL DISPLAY PANEL - 10 mL Cup

    Delivers 10.15 mL

    NDC 0121-1314-11

    A CETAMINOPHEN

    O RAL S OLUTION USP

    325 mg/10.15 mL

    ALCOHOL FREE

    FOR INSTITUTIONAL USE ONLY

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    F06571102

    10 mL Unit Dose Cup Label


  • PRINCIPAL DISPLAY PANEL - 5 mL Cup

    Delivers 5 mL

    NDC 0121-0657-05

    A CETAMINOPHEN

    O RAL S OLUTION USP

    160 mg/5 mL

    ALCOHOL FREE

    FOR INSTITUTIONAL USE ONLY

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    A06570500

    5 mL Unit Dose Cup Label


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0657
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    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:0121-0657-00 10 in 1 CASE 08/01/2007
    1 10 in 1 TRAY
    1 NDC:0121-0657-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2 NDC:0121-0657-11 10 in 1 CASE 08/01/2007
    2 10 in 1 TRAY
    2 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3 NDC:0121-0657-21 10 in 1 CASE 08/01/2007
    3 10 in 1 TRAY
    3 20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 08/01/2007
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1314
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    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:0121-1314-00 10 in 1 CASE 08/01/2007
    1 10 in 1 TRAY
    1 NDC:0121-1314-11 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 08/01/2007
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1971
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    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:0121-1971-00 10 in 1 CASE 08/01/2007
    1 10 in 1 TRAY
    1 NDC:0121-1971-21 20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 08/01/2007
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0657, 0121-1314, 0121-1971)