Childrens Acetaminophen Oral

Manufacturer
P & L Development, LLC
Effective date
2019-04-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:26:06

Label at a glance#

ProductChildrens Acetaminophen Oral Grape Flavor
Active ingredientACETAMINOPHEN
Label structure15 sections

Indications and uses

temporarily reduces fever temporarily 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. • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give more th...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL, 1 teaspoon)
Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen
160 mg.............................Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily reduces fever
temporarily 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 non-prescription).
If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist

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

OTC - ASK DOCTOR/PHARMACIST SECTION

is 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

• 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.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Enter section text here

Overdose Warning

OVERDOSAGE SECTION

Taking more than the
recommended dose (overdose) may cause liver
damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control
Center 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.
• 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 24     under 2           ask a doctor
24-35         2-3                 1 teaspoon or 5 mL
36-47         4-5                 1 1/2 teaspoons or 7.5 mL
48-59         6-8                 2 teaspoons or 10 mL
60-71         9-10               2 1/2 teaspoons or 12.5 mL
72-95         11                  3 teaspoons or 15 mL








Other information

SPL UNCLASSIFIED SECTION

• store at controlled room temperature
• see bottom panel for lot number and
expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

blue 1, butyl paraben, carboxymethylcellulose
sodium, cellulose, citric acid, flavors, glycerin,
high fructose corn syrup, propylene glycol, purified
water, red 33, sodium benzoate, sorbitol, sucralose,
xanthan gum

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label
image of label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
AcetaminophenACTIVE MOIETY362O9ITL9D1
butylparabenINACTIVE INGREDIENT3QPI1U3FV81
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS3111
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
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
49580-341449580-3414-4

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 9 · 515 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii candidate
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAMUSCULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRACARDIAC1.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINHALANT / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSYRUP / ORAL1 mgExact identifier — unii candidate
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE / DENTAL249 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 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
b43e2780-502c-405a-be2b-1ffa12bc228e7b03cb11-1555-4e75-8c2f-616c03f536c52019-04-11WarningsExact identifier
spl id: b43e2780-502c-405a-be2b-1ffa12bc228e
spl set id: 7b03cb11-1555-4e75-8c2f-616c03f536c5

Reported adverse events (FAERS/openFDA)#

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