Childrens Pain and Fever

Manufacturer
AptaPharma Inc.
Effective date
2019-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:21

Label at a glance#

ProductChildrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and uses

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

Dosage and administration

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)               ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient
(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

temporarily

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

1-877-798-5944

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

AptaPharma ChildPainFever LabelAptaPharma ChildPainFever Label

AptaPharma ChildPainFever1 LabelAptaPharma ChildPainFever1 Label

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN2
307668acetaminophen 32 MG/ML Oral SuspensionSCD2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY2
307668APAP 32 MG/ML Oral SuspensionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76281-302-242022-01-28C16284748780-1d6a99b39-3655-a426-e053-dadaa90af4c2eda2a4bd-9bb2-46a7-961d-e3aa1519f67b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-302-24Childrens Pain and Fever118 mL in 1 BOTTLELIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-302CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [APTAPHARMA INC.]2Legacy NDC, 1 package rows20191029_eda2a4bd-9bb2-46a7-961d-e3aa1519f67b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3111
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-30276281-302-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 465 matching rows.

DailyMed ingredient, IID ingredient, UNII table
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GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
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SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
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SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM / SUBLINGUAL11 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
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CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
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SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
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FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / SUBCUTANEOUS101 mgExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
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CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
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CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, CHEWABLE / ORAL24.75 mgExact identifier — unii candidate
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CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM, SOLUBLE / BUCCAL47 mgExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
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BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET, COATED / ORAL0.08 mgExact identifier — unii candidate
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SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii candidate
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XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii candidate
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SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1241bed9-7fd4-48b2-af37-0912896de015eda2a4bd-9bb2-46a7-961d-e3aa1519f67b2019-10-28WarningsExact identifier
spl id: 1241bed9-7fd4-48b2-af37-0912896de015
spl set id: eda2a4bd-9bb2-46a7-961d-e3aa1519f67b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.