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  5. Label Information: Pediacare Childrens Acetaminophen Grape

FDA Label for Pediacare Childrens Acetaminophen Grape

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. PURPOSE
    4. USES
    5. LIVER WARNING
    6. DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE CARTON

Pediacare Childrens Acetaminophen Grape Product Label

The following document was submitted to the FDA by the labeler of this product Randob Labs,ltd. Dba Crossingwell Consumer Health. 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.

Other



Drug Facts

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.

    Distributed by
    CrossingWell
    Consumer Health
    PO Box 440
    Cornwall, NY 12518


Active Ingredient (In Each 5 Ml)



Acetaminophen 160 mg


Purpose



Pain reliever/fever reducer


Uses



temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • headache
    • flu
    • sore throat
    • toothache

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

Do Not Use



  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor



Ask a doctor before use if your child has liver disease


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if your child is 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



  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

    • These could be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



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 for children even if you do not notice any signs or symptoms.


Directions



  • this product does not contain directions or complete warnings for adult use.
  • Shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • only use enclosed measuring syringe
  • 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 doctor

    under 24under 2 yrask a doctor
    24-352-3 yr5 mL

Other Information



  • Store between 15° - 30° C (59° - 86° F)
  • Protect from Freezing
  • Protect from Light

Inactive Ingredients



acesulfame potassium, citric acid, corn syrup, FD&C blue #1, FD&C red #33 flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum


Principal Display Panel - 30 Ml Bottle Carton



Fast Acting
Pedia
Care®
100% dedicated
to kids™

Infants

ACETAMINOPHEN

Pain Reliever/
Fever Reducer

Acetaminophen (160 mg per 5mL)
Oral Suspension

Alcohol Free, Asprin Free
Ibuprofen Free, No Parabens

Grape Flavor
(Use Only Enclosed Syringe)

1 FL OZ (30mL)
160 mg per 5 mL

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - pediacare 01

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - pediacare 01


* Please review the disclaimer below.