Indications and uses
temporarily reduces fever temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Childrens Pain and Fever
- Manufacturer
- Best Choice (Valu Merchandisers Company)
- Effective date
- 2024-02-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:40
Label at a glance#
ProductChildrens 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 take more than directed (see overdose warning) shake well before using mL = mililiter use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by ...
Storage and handling
each 5 mL contains: sodium 2 mg store between 20-25ºC (68-77ºF) do not refrigerate see bottom panel for lot number and expiration date
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
- temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
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.
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
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 non-prescription). 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
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 dosage (see overdose warning)
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
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 a Poison Control Center (1-800-222-1222) right away. 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 take more than directed (see overdose warning)
- shake well before using
- mL = mililiter
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
| Weight (lb) | Age (yr) | Dose (tsp or mL) |
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 5 mL |
| 36-47 | 4-5 | 7.5 ml |
| 48-59 | 6-8 | 10 mL |
| 60-71 | 9-10 | 12.5 mL |
| 72-95 | 11 | 15 mL |
Other information
- each 5 mL contains: sodium 2 mg
- store between 20-25ºC (68-77ºF)
- do not refrigerate
- see bottom panel for lot number and expiration date
Inactive ingredients
citric acid, butylparaben, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Children's Tylenol® Oral Suspension**
Children's
Pain & Fever
Acetaminophen 160 mg per 5 mL
Oral suspension
- Pain Reliever/Fever reducer
- Alcohol free
- Aspirin free
- Ibuprofen free
Grape flavor
For Ages 2-11
Oral suspension
FL OZ (mL)
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
PROUDLY DISTRIBUTED BY:
ASSOCIATED WHOLESALE GROCERS, INC
KANSAS CITY, KANSAS 66106
Product Label
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 7 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 7 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 7 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 7 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 7 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 7 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 7 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63941-288-04 | Childrens Pain and Fever | 118 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 118 | 7 | |
| 63941-288-04 | Childrens Pain and Fever | 1 in 1 BOX | SUSPENSION | 1 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 3 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 3 | |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | INACTIVE INGREDIENT | K679OBS311 | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 3 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 |
Products#
Every source-derived product name is available through these pages.
- Childrens Pain and Fever
- Acetaminophen
- ANHYDROUS CITRIC ACID
- BUTYLPARABEN
- CARBOXYMETHYLCELLULOSE SODIUM
- D&C RED NO. 33
- FD&C BLUE NO. 1
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- CELLULOSE, MICROCRYSTALLINE
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63941-288 | 63941-288-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SYRUP / ORAL | 28.4 mg/1ml | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SHAMPOO / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / RESPIRATORY (INHALATION) | 5 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / RECTAL | 406 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SOLUTION / ORAL | 2 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GRANULE, FOR SUSPENSION / ORAL | 15.63 mg/5ml | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | PASTE, DENTIFRICE / DENTAL | 1.2 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | GEL / TOPICAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRAVITREAL | 0.5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, EMULSION / INTRAVENOUS | 0.1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, COATED / ORAL | 3.2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION / INTRA-ARTICULAR | 25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY / NASAL | 2 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | CREAM / TOPICAL | 0.4 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SOLUTION / DENTAL | NA | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | TABLET, COATED / ORAL | 0.08 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / BUCCAL | 9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION/ DROPS / AURICULAR (OTIC) | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg |
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 |
|---|---|---|---|---|---|---|
| a653fff4-8b9e-4aff-ab0c-1d153077bf32 | 25b25357-2caa-42f5-ab59-be66b9e2635f | 2026-06-11 | Warnings | 25b25357-2caa-42f5-ab59-be66b9e2635f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.