Indications and uses
temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
Sunmark Infants Pain and Fever
- Manufacturer
- Strategic Sourcing Services LLC
- Effective date
- 2024-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:48:58
Label at a glance#
ProductSunmark Infants Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections
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. If possible, use weight to dose; otherwise, use age. • push air out of syringe. Insert syringe tip into bottle opening. • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push...
Storage and handling
• store at 20-25°C (68-77°F) • do not use if printed neckband is broken or missing
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
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
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
- 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
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 occur
- redness or swelling is present. These could be signs of a serious condition.
Keep out of reach of children.
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
- 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. If possible, use weight to dose; otherwise, use age.
- push air out of syringe. Insert syringe tip into bottle opening.
- flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
- pull yellow part of syringe until it reaches and stays at the correct dose
- dispense liquid slowly into child’s mouth, toward inner cheek
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- replace cap tightly to maintain child resistance
Dosing Chart | ||
Weight (lb) | Age (yr) | Dose (mL)* |
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 5 mL |
* or as directed by a doctor
Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.
Other information
- store at 20-25°C (68-77°F)
- do not use if printed neckband is broken or missing
Inactive ingredients
anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, 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?
1-800-719-9260
Package/Label Principal Display Panel
sunmark®
COMPARE TO INFANTS’ TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT
infants’
pain & fever
Acetaminophen 160 mg per 5 mL
PAIN RELIEVER/FEVER REDUCER
For ages 2 to 3 years
Suspension Liquid
Aspirin Free
Ibuprofen Free
Alcohol Free
Paraben Free
Pediatrician Preferred Dosing System
Use only with enclosed syringe.
See side panel for more information.
GRAPE FLAVOR
GLUTEN FREE
2 FL OZ (59 mL)
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-430-30 | ML - Milliliter | 49348-430 | 36537126-41b6-4555-806e-510626b59b37 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| 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 BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 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.
- Sunmark Infants Pain and Fever
- Acetaminophen
- ANHYDROUS CITRIC ACID
- CALCIUM SULFATE, UNSPECIFIED FORM
- CARRAGEENAN
- D&C RED NO. 33
- FD&C BLUE NO. 1
- 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 |
|---|---|
| 49348-430 | 49348-430-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / BUCCAL | 9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, EMULSION / INTRAVENOUS | 0.1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM / BUCCAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | DROPS / ORAL | NA | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SYRUP / ORAL | 28.4 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 12 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CLOTH / TOPICAL | 4.2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL / TOPICAL | 0.08 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / ORAL | 197 mg | ||
| SODIUM PHOSPHATE, TRIBASIC | SODIUM PHOSPHATE, TRIBASIC | A752Q30A6X | POWDER, FOR SUSPENSION / ORAL | 650 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRA-ARTICULAR | 45 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE / ORAL | 4 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION / ORAL | 20000 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | AEROSOL, FOAM / VAGINAL | 0.2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRAVITREAL | 0.5 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CAPSULE / ORAL | 8.5 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | TABLET, FILM COATED / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, LIQUID FILLED / ORAL | 0.01 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SOLUTION / ORAL | 10000 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a1b066f5-9e9b-4d63-88af-40f4374ed5dd | 83acab73-3efb-4ea6-ad03-31b82dd017b9 | 2024-11-21 | Warnings | a1b066f5-9e9b-4d63-88af-40f4374ed5dd 83acab73-3efb-4ea6-ad03-31b82dd017b9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.