Indications and uses
temporarily: • reduces fever • relieves minor aches and pain due to: • the common cold • flu • headache • sore throat • toothache
Childrens Pain and Fever
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Effective date
- 2024-05-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:02:34
Label at a glance#
ProductChildrens 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 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 2...
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 pain 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 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 the 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 sign 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 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
- each 5 mL contains: sodium 2 mg
- store at 20° to 25°C (68° to 77°F)
- do not use if printed neckband is broken or missing
Inactive ingredients:
acesulfame K, butylparaben, citric acid, D&C Red No. 33, FD&C Blue No. 1, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
Questions or comments?
1-800-845-8210
**This product is not manufactured or distributed by
Johnson & Johnson Consumer Inc., distributor of
Children’s Tylenol® Oral Suspension.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-38612
Principal Display Panel
Compare to the active ingredient in Children’s Tylenol® Oral Suspension**
Suspension Liquid
NDC 0121-0973-08
Children’s Pain & Fever
ACETAMINOPHEN
160 mg / 5 mL
Pain reliever; Fever reducer
Ages 2 to 11 years
Free of:
• Added Alcohol
• Aspirin
• Ibuprofen
Grape Flavor
Use ONLY Enclosed Dosing Cup
Actual Bottle Size on Side Panel
8 FL OZ (237 mL)
Products#
Every source-derived product name is available through these pages.
- Childrens Pain and Fever
- ACETAMINOPHEN
- ACESULFAME POTASSIUM
- BUTYLPARABEN
- CITRIC ACID ACETATE
- D&C RED NO. 33
- FD&C BLUE NO. 1
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- POLYSORBATE 80
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL SOLUTION
- XANTHAN GUM
- MAGNESIUM ALUMINUM SILICATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0121-0973 | 0121-0973-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| CITRIC ACID ACETATE | DSO12WL7AU | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
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 |
|---|---|---|---|---|---|---|
| d7446eee-dd37-47df-9f8f-dd740d1185ab | 10467f34-d9b1-41ff-9493-af6b649eb322 | 2024-05-15 | Warnings | d7446eee-dd37-47df-9f8f-dd740d1185ab 10467f34-d9b1-41ff-9493-af6b649eb322 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.