Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Children Pain and Fever
- Manufacturer
- Method Pharmaceuticals, LLC
- Effective date
- 2020-07-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:23:36
Label at a glance#
ProductChildren Pain and Fever
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) mL = milliliter find the right dose on chart below. If possible, use weight to dose: otherwise, use age. remove the child protective cap and dispense 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 (l...
Storage and handling
each 5 mL contains: sodium 3 mg store at 20°C to 25°C (68°F to 77°F) do not use if seal is broken or missing
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Children’s Pain & Fever
Acetaminophen Liquid 160 mg/5 mL
Pain Reliever / Fever Reducer
Oral Solution
Alcohol Free/ Aspirin Free/ Ibuprofen Free
Ages 2-11 Years
Cherry Flavor
Drug Facts
Active ingredient (in each 5 mL teaspoonful
Acetaminophen, USP 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 you take:
- 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 other drugs 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 10 days
- fever gets worse or last for 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)
- mL = milliliter
- find the right dose on chart below. If possible, use weight to dose: otherwise, use age.
- remove the child protective cap and dispense 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 3 mg
- store at 20°C to 25°C (68°F to 77°F)
- do not use if seal is broken or missing
Inactive Ingredients
FD&C Red #40, Flavor, Glycerin, Masking Agent, Polyethylene Glycol, Citric Acid, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol
Questions or comments?
1-877-250-3427
Manufactured for:
Method Pharmaceuticals
, LLC
Fort Worth, Texas 76118
Rev. 04/2020
Principal Display Panel
NDC 58657-521-04
Method Pharmaceuticals
Children’s
Pain & Fever
Acetaminophen 160 mg per 5 mL
Cherry Flavor
4 fl. Oz. (118 mL)
Products#
Every source-derived product name is available through these pages.
- Children Pain and Fever
- Acetaminophen
- FD&C RED NO. 40
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- CITRIC ACID MONOHYDRATE
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE
- SACCHARIN SODIUM
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58657-521 | 58657-521-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| d47493cc-94ce-3d68-e053-2a95a90aca4b | 457d0630-6bc0-4a60-a44c-9c2b490e648b | 2021-12-31 | Warnings | 457d0630-6bc0-4a60-a44c-9c2b490e648b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.