Indications and uses
temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
Infants Pain Relief
- Manufacturer
- Publix Super Markets Inc
- Effective date
- 2024-10-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:32:25
Label at a glance#
ProductInfants Pain Relief
Active ingredientACETAMINOPHEN
Label structure8 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 68-77 ° F (20-25 ° C) • 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 68-77°F (20-25°C)
- do not use if printed neckband is broken or missing
Inactive ingredients
anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate
Package/Label Principal Display Panel
P
FOR AGES 2-3 YEARS
INFANTS’
pain relief
ACETAMINOPHEN
160 mg PER 5 mL
PAIN RELIEVER/FEVER REDUCER
SUSPENSION LIQUID
• Ibuprofen free
• Alcohol free
• Aspirin free
• Paraben free
GRAPE FLAVOR
NO HIGH FRUCTOSE CORN SYRUP
USE ONLY WITH ENCLOSED SYRINGE.
DYE-FREE
PEDIATRICIAN PREFERRED DOSING SYSTEM
SEE SIDE PANEL FOR MORE INFORMATION.
2 FL OZ (59 mL)
†Compare to Infants’ Tylenol® Oral Suspension active ingredient
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 4 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 4 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 4 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 4 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 4 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 4 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 4 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 56062-766-16 | Infants Pain Relief | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 56062-766-16 | Infants Pain Relief | 59 mL in 1 BOTTLE | SUSPENSION | 59 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Infants Pain Relief
- Acetaminophen
- ANHYDROUS CITRIC ACID
- CALCIUM SULFATE, UNSPECIFIED FORM
- CARRAGEENAN
- GLYCERIN
- HYDROXYETHYL CELLULOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- SODIUM PHOSPHATE, TRIBASIC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 56062-766 | 56062-766-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Infants Pain Relief | ACETAMINOPHEN | Publix Super Markets Inc | 0bc33897-afc2-4d11-be6c-a26480f448bf | 2024-10-31 | Warnings | 56062-766-16 56062-766 56062076616 23548bf3-6bc6-41c7-ac76-ba1e7593f0cc 0bc33897-afc2-4d11-be6c-a26480f448bf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.