Childrens Pain Relief and Fever Reducer
- Manufacturer
- Plastikon Healthcare, LLC
- Effective date
- 2021-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:22:19
Label at a glance#
ProductChildrens Pain Relief and Fever Reducer
Active ingredientACETAMINOPHEN
Label structure2 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Children's Pain Relief and Fever Reducer Acetaminophen Oral Solution 160 mg/ 5 mL Unit Dose Cup
Single Use Measurements
for easy, accurrate dosing.
Compare to the Active Ingredient in
Children's Tylenol® Pain + Fever Relief Liquid*
CORRECTDOSE®
Precise - Portable - Single-use
Children's
PAIN RELIEF
& FEVER REDUCING
For Ages: 2-3**
Acetaminophen Oral Solution
12
PRE-FILLED
SINGLE-USE
DOSES
CHERRY
Ibuprofen Free
Aspirin Free
2.04 FL. OZ (60 mL)
12 - 5 mL Individual Doses
Children's Pain Relief & Fever Reducer 160 mg / 5 mL Unit Dose Vial/Ampoule
Directions
- do not exceed 5 doses (5 vials) in a 24 hour period
- give the recommended number of vials below folloiwn gthe instructions under "How to Use" on the back panel
- if the child is not in the listed weight range, consult a physician before use
- empty each single-use vial required, of all liquid when dosing
- this product does not include dosing or complete warnings for adult use
Age (yr) | Weight (lbs) | Dose (mL) | ||
2-3 years | 24-35 lbs | 1 Single-use vial (5 mL) every 4 hours Do not exceed 5 does in a 24 period |
Children's Pain Relief & Fever Reducer 160 mg / 5 mL
Keep out of reach of children.
Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for children even if you do not notice any signs or symptoms.
Children's Pain Relief & Fever Reducer 160 mg / 5 mL
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 the child is allergic to acetaminophen or any other inactive ingredients in this product
____________________________________________________________________________
Ask a doctor before use if
- the child has liver disease
____________________________________________________________________________
Ask a doctor or pharmacist before use
- if the child is taking the blood thinning drug Warfarin
____________________________________________________________________________
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
These could be signs of a serious condition
Children's Pain Relief & Fever Reducer 160 mg / 5 mL
Inactive ingredientsAnhydrous Ctric acid, Cherry flavor, Glycerin, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Benzoate, Sorbitol, Sucralose
Children's Pain Relief & Fever Reducer 160 mg / 5 mL
Uses temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- premenstrual and menstrual cramps
- the common cold
- headache
- toothache
- temporarily reduces fever
Children's Pain Relief & Fever Reducer 160 mg / 5 mL
Active ingredient (in each 5 mL unit)
Acetaminophen USP 160 mg
Children's Pain Relief & Fever Reducer 160 mg / 5 mL
Pain reliever / fever reducer
Children's Pain Relief & Fever Reducer 160 mg / 5 mL
Other information
- store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)
- protect from excessive moisture
- do not use if foile lid seal is open or damaged
- see bottom of bag for lot number and expiration date
- sugar free, dye free, alcohol free
Children's Pain Relief & Fever Reducer 160 mg / 5 mL Unit Dosing Ampoule Pouch
CORRECTDOSE®
Precise - Portable - Single-use
Children's
PAIN RELIEF
&
Fever Reducer
Acetaminophen Oral Solution
Cherry
For Ages: 2-3**
1
PRE-FILLED
SINGLE-USE
DOSE
Lasts up to
4 HOURS
WARNING:
CHOKING HAZARD
-SMALL PARTS
KEEP OUT OF REACH
OF SMALL CHILDREN
0.17 FL. OZ (5 mL)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62320-311-05 | 2022-09-23 | C162847 | 48780-1 | e4f33bdf-a5c4-d8a0-e053-dadaa90a6e4e | Childrens Acetaminophen Pain Relief & Fever Reducer 160 mg/5 mL |
| 62320-311-05 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a5c4-d8a0-e053-dadaa90a6e4e | Childrens Acetaminophen Pain Relief & Fever Reducer 160 mg/5 mL |
Products#
Every source-derived product name is available through these pages.
- Childrens Pain Relief and Fever Reducer
- Acetaminophen Oral Solution
- GLYCERIN
- SODIUM BENZOATE
- ANHYDROUS CITRIC ACID
- SORBITOL
- SUCRALOSE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- ACETAMINOPHEN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62320-311 | 62320-311-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| e95f150e-3c74-7cb8-e053-2a95a90a9cb4 | c0e504cd-730a-327d-e053-2a95a90aca55 | 2022-09-23 | Warnings | c0e504cd-730a-327d-e053-2a95a90aca55 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.