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Childrens Pain and Fever by AptaPharma Inc.

Medically reviewed on Dec 20, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: AptaPharma Inc.
NDC Code: 76281-302

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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




CHILDRENS PAIN AND FEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-302
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:76281-302-24118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/21/2013
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIOperations
AptaPharma Inc.790523323manufacture(76281-302)

 
AptaPharma Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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