Childrens Pain Relief

Manufacturer
Chain Drug Consortium (Premier Value) | davAgen Pharmaceutical, LLC
Effective date
2014-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:45

Label at a glance#

ProductChildrens Pain Relief
Active ingredientAcetaminophen
Label structure11 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 find right dose on chart below. If possible, use weight to dose: otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device tsp = teaspoon, mL = milliliter if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours d...

Storage and handling

store at controlled room temperature dosage cup provided each teaspoon contains: sodium 2 mg

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL, 1 teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 - DO NOT USE SECTION

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 SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Overdose Warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical 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
  • find right dose on chart below. If possible, use weight to dose: otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device
  • tsp = teaspoon, mL = milliliter
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
Weight (lb)Age (yr)Dose (tsp or mL)
under 24under 2ask a doctor
24-352-31 tsp or 5 mL
36-474-51½ tsps or 7.5 mL
48-596-82 tsps or 10 mL
60-719-102½ tsps or 12.5 mL
72-95113 tsps or 15 mL

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature
  • dosage cup provided
  • each teaspoon contains: sodium 2 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose, FD&C Blue #1, D&C Red #33, Flavors, Glycerin, High Fructose Corn Syrup, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol 1450, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sorbitol Solution, Sucralose Powder, Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

1-732-249-6363

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-141-04

Premier
Value ®

Children's
Pain Relief

PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
SUSPENSION LIQUID

• Alcohol Free
• Aspirin Free
• Ibuprofen Free

Grape
Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

Principal Display Panel - 118 mL Bottle Label
Principal Display Panel - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN1
307668acetaminophen 32 MG/ML Oral SuspensionSCD1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY1
307668APAP 32 MG/ML Oral SuspensionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-141-042020-01-31C16284748780-19d75b9d0-922c-f424-e053-dadaa90a57ceChildren's Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-141-04Childrens Pain Relief1 in 1 CARTONLIQUID11
68016-141-04Childrens Pain Relief118 mL in 1 BOTTLE, PLASTICLIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-141CHILDRENS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1Legacy NDC, 2 package rows20141106_e697cdaf-b842-41ed-bb05-a324de0533d8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
AcetaminophenACTIVE MOIETY362O9ITL9D1
CarboxymethylcelluloseINACTIVE INGREDIENT05JZI7B19X1
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0L1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQK1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
High Fructose Corn SyrupINACTIVE INGREDIENTXY6UN3QB6S1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
Polyethylene Glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L41
Powdered CelluloseINACTIVE INGREDIENTSMD1X3XO9M1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY1
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 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-14168016-141-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 9 · 492 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C Blue No. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
D&C Red No. 33D&C RED NO. 339DBA0SBB0LCONCENTRATE / ORAL0.02 mg/1mlExact identifier — unii candidate
14 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
Powdered CellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / BUCCAL4.5 mgExact identifier — unii candidate
16 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
SorbitolSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CarboxymethylcelluloseCARBOXYMETHYLCELLULOSE05JZI7B19XTABLET / ORAL45 mgExact identifier — unii candidate
8 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
Polyethylene Glycol 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET / ORAL0.6 mgExact identifier — unii candidate
8 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET / SUBLINGUAL12 mgExact identifier — unii candidate
22 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates

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
fc3a8014-1886-40f7-8c7e-5ae4fe359450e697cdaf-b842-41ed-bb05-a324de0533d82014-10-27WarningsExact identifier
spl id: fc3a8014-1886-40f7-8c7e-5ae4fe359450
spl set id: e697cdaf-b842-41ed-bb05-a324de0533d8

Reported adverse events (FAERS/openFDA)#

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