Indications and uses
▪ temporarily: ▪ reduces fever ▪ relieves minor aches and pains due to: ▪ the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache
CVS Children’s Pain + Fever Relief
- Manufacturer
- CVS PHARMACY
- Effective date
- 2026-08-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-08-18 02:02:44
Label at a glance#
ProductCVS Childrens Pain plus Fever Relief
Active ingredientACETAMINOPHEN
Label structure10 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 ...
Storage and handling
▪ each 5 mL contains : sodium 2 mg ▪ store at room temperature
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
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
SPL UNCLASSIFIED SECTION
- 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.
SPL UNCLASSIFIED SECTION
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 is allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 for adults as well as for children 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 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 |
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 room temperature
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose sodium, D&C Red No. 33, FD&C Blue No. 1, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum
Questions or comments?
1-866-467-2748
PRINCIPAL DISPLAY PANEL
Compare to the active ingredient in Children’s Tylenol® Oral Suspension*
NDC 51316-695-04
Children’s
Pain+Fever Relief
Acetaminophen
Oral Suspension
Pain Reliever-Fever Reducer
- No Added Alcohol
- Sugar Free
- Aspirin Free
- Ibuprofen Free
- No Parabens
Ages 2-11 Years
Grape Flavor
Naturally Flavored
4 FL. OZ. (120 mL)
160 mg per 5 mL
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. distributer of Children’s Tylenol® Oral Suspension.
Distributed by:
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- CVS Childrens Pain plus Fever Relief
- Acetaminophen
- ANHYDROUS CITRIC ACID
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- D&C RED NO. 33
- FD&C BLUE NO. 1
- GLYCERIN
- MICROCRYSTALLINE CELLULOSE
- WATER
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- SORBITOL SOLUTION
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-695 | 51316-695-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-12-09 | full-release | 2026-06-01 01:20:49 |
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 |
|---|---|---|---|---|---|---|
| CVS Childrens Pain plus Fever Relief | ACETAMINOPHEN | CVS PHARMACY | 22a48a33-995b-481e-9e4e-1ad7ec346f44 | 2026-08-14 | Warnings | 51316-695-04 51316-695 51316069504 f8c392f4-4984-4b07-852b-b9ebd2c347b5 22a48a33-995b-481e-9e4e-1ad7ec346f44 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.