Indications and uses
temporarily reduces fever temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Childrens Acetaminophen
- Manufacturer
- Family Dollar (FAMILY WELLNESS)
- Effective date
- 2023-01-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:39:52
Label at a glance#
ProductChildrens Acetaminophen
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 direc...
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
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you 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. 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 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 = 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 (year) | 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 |
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
butylparaben, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, ssucralose, 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 Reliever + Fever Reducer
Acetaminophen 160 mg per 5 mL
Oral suspension
For Ages 2 - 11 Years
Alcohol Free
Aspirin Free
Ibuprofen Free
FL OZ (mL)
GRAPE FLAVOR
**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: MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
Product Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-288-04 | 2023-01-20 | C162847 | 48780-1 | d6a99b39-b94c-a426-e053-dadaa90af4c2 | Drug Facts |
| 55319-288-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b94c-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Childrens Acetaminophen
- 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 |
|---|---|
| 55319-288 | 55319-288-04 |
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, METERED / TOPICAL | 1225 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRA-ARTICULAR | 30 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 12 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM / BUCCAL | 1 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CLOTH / TOPICAL | 4.2 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TROCHE / ORAL | 948 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRAVITREAL | 0.5 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SUSPENSION / ORAL | 560 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / BUCCAL | 5110 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / SOFT TISSUE | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE / ORAL | 131 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | LOTION / TOPICAL | NA | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SYRUP / ORAL | 28.4 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LOZENGE / TRANSMUCOSAL | 44 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE, DENTIFRICE / DENTAL | 0.5 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYRUP / ORAL | 26.5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 35 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, FILM COATED / ORAL | 50 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / ORAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 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 |
|---|---|---|---|---|---|---|
| a8d119d0-701a-4581-82fc-818a14c9500b | 5b77bb9b-3947-443c-9794-b3ea5922c72c | 2023-01-20 | Warnings | a8d119d0-701a-4581-82fc-818a14c9500b 5b77bb9b-3947-443c-9794-b3ea5922c72c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.