Childrens Pain And Fever
FDA Label NDC 76281-302

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Childrens Pain And Fever (NDC 76281-302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Drug Facts

Active ingredient
(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

temporarily

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

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

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 your child is allergic to acetaminophen or any other of the inactive ingredients in this product.

Ask A Doctor Before Use If Your Child Has

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

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
  • redness or swelling is present  These could be signs of a serious condition.

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;   tsp = teaspoonful
find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give for more than 5 days unless directed by a doctor.

Weight (lb)                                      Age (yr)                                        Dose (mL or  tsp)*

under 24                                     under 2 years                                      ask a doctor

24-35                                              2 - 3 years                                      5 mL (1 tsp)

36-47                                              4 - 5 years                                      7.5 mL (1 1/2 tsp0

48-59                                              6 - 8 years                                      10 mL (2 tsp)

60-71                                             9 - 10 years                                     12.5. mL (2 1/2 TSP)

72-95                                                  11 years                                     15 mL (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.                   

Other Information

  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20-25° C (68-77° F)
  • do not refrigerate

Inactive Ingredients

anhydrous citric acid, butylparaben, FD and C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethycellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

SOUND BODY™

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S TYLENOL® ORAL SUSPENSION

Children's

Pain and Fever

Acetaminophen

Oral Suspension
     Alcohol Free
    Ibuprofen Free
    Aspirin Free

For Ages 2 to 11

CHERRY FLAVORED

4 FL OZ (118 mL)
160 mg per 5 mL

DO NOT USE IF PRINTED NECKBAND IA BROKEN OR MISSING

*This product is not manufactures or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension.

Manufactured by:
AptaPharma Inc.,
1533 Union Ave
Pennsauken, NJ 08110

V#5002632    ITEM#302

BX-003 Rev 1


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* Please review the disclaimer below.