Sunmark childrens pain and fever

Manufacturer: Strategic Sourcing Services LLC
Effective date: 2025-02-26
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-01 20:41:02

Label at a glance#

ProductSunmark childrens pain and fever

Active ingredientACETAMINOPHEN

Label structure9 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 • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more t...

Storage and handling

• each 5 mL contains: sodium 3 mg • store at 20-25°C (68-77°F) • do not use if printed neckband is broken or missing

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

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: 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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 has ever had an allergic reaction to this product or any of its ingredients

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 occur
redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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
do not give more than directed (see overdose warning)
shake well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
remove the child protective cap and squeeze your child’s dose into the dosing cup
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)*
under 24	under 2 years	ask a doctor
24-35	2-3 years	5 mL
36-47	4-5 years	7.5 mL
48-59	6-8 years	10 mL
60-71	9-10 years	12.5 mL
72-95	11 years	15 mL

*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

STORAGE AND HANDLING SECTION

each 5 mL contains: sodium 3 mg
store at 20-25°C (68-77°F)
do not use if printed neckband is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark®

COMPARE TO CHILDREN’S TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT

children’s pain & fever

Acetaminophen 160 mg per 5 mL

PAIN RELIEVER

FEVER REDUCER

For ages 2 to 11 years

Suspension Liquid

Aspirin Free

Alcohol Free

Ibuprofen Free

Paraben Free

BUBBLE GUM FLAVOR

GLUTEN FREE

4 FL OZ (118 mL)

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-093	SUNMARK CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [STRATEGIC SOURCING SERVICES LLC]	9	Legacy NDC	20250227_9100dfb8-62fe-4093-bf19-286ce99be076.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-093-34	ML - Milliliter	49348-093	5ed8306f-0ba1-4218-a182-c6e27d9fd242	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	2
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	2
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM PHOSPHATE, TRIBASIC	INACTIVE INGREDIENT	A752Q30A6X	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Sunmark childrens pain and fever
Acetaminophen
ANHYDROUS CITRIC ACID
CALCIUM SULFATE, UNSPECIFIED FORM
CARRAGEENAN
D&C RED NO. 33
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
MICROCRYSTALLINE CELLULOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL SOLUTION
SODIUM PHOSPHATE, TRIBASIC
HYDROXYETHYL CELLULOSE, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49348-093	49348-093-34

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
CALCIUM SULFATE, UNSPECIFIED FORM	WAT0DDB505	IACT
CARRAGEENAN	5C69YCD2YJ	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT
SODIUM PHOSPHATE, TRIBASIC	A752Q30A6X	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT

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 · 447 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRAMUSCULAR		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SHAMPOO / TOPICAL	0.07 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LOZENGE / TRANSMUCOSAL		44 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / OPHTHALMIC	0.09 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / SUBCUTANEOUS		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	CAPSULE / ORAL	141.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CLOTH / TOPICAL	4.2 mg		Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRACARDIAC		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / TOPICAL	4.35 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAMUSCULAR		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LIQUID / INTRAVENOUS		18 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2c0cb26e-d3d9-4bdb-8f7d-6ff0330603ae			9100dfb8-62fe-4093-bf19-286ce99be076	2025-02-26	Warnings	Exact identifier spl id: 2c0cb26e-d3d9-4bdb-8f7d-6ff0330603ae spl set id: 9100dfb8-62fe-4093-bf19-286ce99be076

Reported adverse events (FAERS/openFDA)#

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