Indications and uses
temporarily reduces fever temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Pain and Fever
- Manufacturer
- Walgreens
- Effective date
- 2020-11-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:07:33
Label at a glance#
ProductPain and Fever Childrens
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 = milliliter use only the 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 directe...
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
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.Symptom may included:
- 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 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 dose (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 = milliliter
- use only the 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 (years) | Dose (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 |
*or as directed by a doctor
Other information
- each 5 mL contains: sodium 2 mg
- store at 20-25ºC (68º-77ºF).
- Do not refrigerate.
- see bottom panel for lot number and expiration date
Inactive ingredients
butyl paraben, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavour, 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 Childrens's Tylenol® Oral Suspension active ingredient††
children's
Pain & Fever
ACETAMINOPHEN 160 mg PER 5 mL
PAIN RELIEVER /
FEVER REDUCER
ORAL SUSPENSION
ASPIRIN FREE
IBUPROFEN FREE
ALCOHOL FREE
BUBBLE GUM FLAVOR
AGES 2-11 YEARS
DOSAGE CUP PROVIDED
††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.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Package Label
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0281-04 | ML - Milliliter | 0363-0281 | f0f8d722-a6b2-47d0-a7ec-b50218dbe8c0 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 2 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 2 | |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | INACTIVE INGREDIENT | K679OBS311 | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 2 |
Products#
Every source-derived product name is available through these pages.
- Pain and Fever Childrens
- Acetaminophen
- BUTYLPARABEN
- CARBOXYMETHYLCELLULOSE SODIUM
- CELLULOSE, MICROCRYSTALLINE
- ANHYDROUS CITRIC ACID
- D&C RED NO. 33
- FD&C RED NO. 40
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0281 | 0363-0281-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | 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 |
|---|---|---|---|---|---|---|
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAMUSCULAR | 864 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CLOTH / TOPICAL | 4.2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, LIQUID FILLED / ORAL | 0.01 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, EXTENDED RELEASE / ORAL | 933 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GRANULE / ORAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SUSPENSION / INTRAMUSCULAR | 0.7 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | TABLET / ORAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | PASTE, DENTIFRICE / DENTAL | 1.2 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | OINTMENT / TOPICAL | 0.18 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SUSPENSION / ORAL | 560 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAMUSCULAR | 101 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / INTRAVENOUS | 4050 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / SUBLINGUAL | 36 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | GEL / TOPICAL | 3 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / BUCCAL | 9 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, SOLUTION / INTRAMUSCULAR | 4.8 %w/v | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION / ORAL | 0.13 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE / ORAL | 131 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / OPHTHALMIC | 0.02 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 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 |
|---|---|---|---|---|---|---|
| 6e157a61-05f9-4ca2-986d-4cc817ef391b | 462c2615-b494-4cba-95c3-d7fc354dbe82 | 2020-11-11 | Warnings | 6e157a61-05f9-4ca2-986d-4cc817ef391b 462c2615-b494-4cba-95c3-d7fc354dbe82 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.