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  5. Label Information: Childrens Acetaminophen Oral Suspension

FDA Label for Childrens Acetaminophen Oral Suspension

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USESTEMPORARILY:
    4. WARNINGS
    5. DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF:
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OVERDOSE WARNING:
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS:
    15. QUESTIONS OR COMMENTS?
    16. OTHER
    17. PRINCIPAL DISPLAY PANEL – TRAY – 160 MG/5 ML
    18. PRINCIPAL DISPLAY PANEL – CUP – 160 MG/5 ML

Childrens Acetaminophen Oral Suspension Product Label

The following document was submitted to the FDA by the labeler of this product American Health Packaging. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



(in each 5 mL)
Acetaminophen160 mg


Purpose



Pain reliever/fever reducer


Warnings



Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes

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

    • 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.


Otc - Ask Doctor



Ask a doctor before use if your child hasliver disease.


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if your childis taking the blood thinning drug warfarin


Otc - When Using



When using this product do not exceed recommended dose (see overdose warning)


Stop Use And Ask A Doctor If:



  • pain gets worse or lasts more than 5 days
  • 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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning:



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 sign or symptoms.


Directions



  • this product does not contain directions or complete warnings for adult use.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

    • Weight (lb)

    Age (yr)

    Dose (mL)

    or as directed by a doctor

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL (1 unit dose cup)

    36-47

    4-5 years

    7.5 mL (1.5 unit dose cups)

    48-59

    6-8 years

    10 mL (2 unit dose cups)

    60-71

    9-10 years

    12.5 mL (2.5 unit dose cups)

    72-95

    11 years

    15 mL (3 unit dose cups)


Other Information



  • each 5 mL contains:sodium: 2 mg
  • Store at 20° to 25°C (68° to 77°F)

    grape flavored suspension supplied in the following oral dosage form:
    5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-762-17


Inactive Ingredients:



acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.


Questions Or Comments?



Call 1-800-845-8210.


Other



DO NOT USE IF SEAL IS BROKEN.

Distributed by:
American Health Packaging
Columbus, OH 43217

T0966C050423
R04/23


Principal Display Panel – Tray – 160 Mg/5 Ml



160 mg/5 mL Children’s Acetaminophen Oral Suspension Tray Label - APAP Tray

160 mg/5 mL Children’s Acetaminophen Oral Suspension Tray Label - APAP Tray

Case NDC 60687-762-17/Cup NDC 60687-762-40

Children’s Acetaminophen
Oral Suspension
160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

USUAL DOSAGE:See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only.

T0966C050423            R04/23


Principal Display Panel – Cup – 160 Mg/5 Ml



160 mg/5 mL Children’s Acetaminophen Oral Suspension Cup - APAP Cup

160 mg/5 mL Children’s Acetaminophen Oral Suspension Cup - APAP Cup

NDC 60687- 762-40

CHILDREN’S
ACETAMINOPHEN
ORAL SUSPENSION

Pain Reliever-Fever Reducer

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free

Delivers 5 mL

SHAKE WELL BEFORE USING

See package Drug Facts inert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0966C50423


* Please review the disclaimer below.