Indications and uses
Temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache Temporarily reduces fever
Children's ACCUDIAL ® Acetaminophen Oral Solution
- Manufacturer
- Accudial Pharmaceutical, Inc.
- Effective date
- 2011-10-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:30:00
Label at a glance#
ProductAcetaminophen
Active ingredientAcetaminophen
Label structure12 sections
Dosage and administration
This product does not contain directions or complete warnings for adult use. shake well before using if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose. when weight is unknown: use the age chart on the rotating label. use only enclosed dosing syringe an...
Storage and handling
each teaspoon contains: sodium 2 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient Purpose (in each 5 mL = 1 teaspoon)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Temporarily reduces fever
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.
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.
OTC - DO NOT USE SECTION
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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease.
Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
When using this product
Do not use more than directed.
Stop use and ask a doctor if
- Pain gets worse or lasts more than 5 days.
- Fever gets worse or lasts more than 3 days.
- New symptoms occur.
- Redness or swelling is present.
These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt 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.
- shake well before using
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
- when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.
when weight is unknown: use the age chart on the rotating label. - use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device
| Age (yr) | Dose (mL or tsp) |
|---|---|
| under 6 mos. | ask a doctor |
| 6 mos. to under 2 | 2.5 mL or ½ tsp. |
| 2 to under 4 | 5 mL or 1 tsp. |
| 4 to under 6 | 7.5 mL or 1½ tsp. |
| 6 to under 9 | 10 mL or 2 tsp. |
| 9 to under 11 | 12.5 mL or 2½ tsp. |
| 11 to under 12 | 15 mL or 3 tsp. |
| or as directed by a doctor | |
| tsp. = teaspoon | mL = milliliter |
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
Other information
- each teaspoon contains: sodium 2 mg
- store between 20°-25°C (68°-77°F)
- tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Inactive ingredients
artificial flavor, citric acid anhydrous USP, D&C Red #33, FD&C Red #40, glycerin USP, non-crystalline sorbitol 70% USP, polyethylene glycol NF, propylene glycol, purified water, sodium benzoate, sodium saccharin.
Questions?
877-434-2036
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC.
Palm Beach Gardens, FL 33408
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Children's
ACCUDIAL
®
Acetaminophen
Oral Solution
Pain Reliever / Fever Reducer
For ages 6 mos. to
under 12 or 12-95 lbs.
Alcohol Free • Aspirin Free • Ibuprofen Free
Compares to the active
ingredient in Children's
Tylenol® Oral Solution.
ROTATING
LABEL FOR
WEIGHT-BASED
DOSING
Cherry Flavor
4 FL. OZ. (120 mL)
80 mg per 1/2 teaspoon
(160 mg per 5 mL)
NDC 45014-130-04
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 1 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 1 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 1 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 1 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 1 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 1 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 1 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45014-130-04 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c770-f6ea-e053-dbdaa90aa703 | Children's ACCUDIAL ® Acetaminophen Oral Solution |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45014-130-04 | Acetaminophen | 120 mL in 1 BOTTLE | LIQUID | 120 | 1 |
DailyMed Dashboard NDC Coverage#
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 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| FD&C Red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| POLYETHYLENE GLYCOL 1450 | INACTIVE INGREDIENT | OJ4Z5Z32L4 | 1 | |
| Propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Prunus Serotina Bark | INACTIVE INGREDIENT | 5D48E975HA | 1 | |
| saccharin sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- Glycerin
- Sorbitol
- Sodium Benzoate
- Anhydrous citric acid
- FD&C Red no. 40
- Water
- saccharin sodium
- Propylene glycol
- Prunus Serotina Bark
- POLYETHYLENE GLYCOL 1450
- D&C RED NO. 33
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45014-130 | 45014-130-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Glycerin | PDC6A3C0OX | IACT |
| Sorbitol | 506T60A25R | IACT |
| Sodium Benzoate | OJ245FE5EU | IACT |
| Anhydrous citric acid | XF417D3PSL | IACT |
| FD&C Red no. 40 | WZB9127XOA | IACT |
| Water | 059QF0KO0R | IACT |
| saccharin sodium | SB8ZUX40TY | IACT |
| Propylene glycol | 6DC9Q167V3 | IACT |
| Prunus Serotina Bark | 5D48E975HA | IACT |
| POLYETHYLENE GLYCOL 1450 | OJ4Z5Z32L4 | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | 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 |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / OPHTHALMIC | 0.09 %w/v | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | PASTE / DENTAL | 0.08 %w/w | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / SUBCUTANEOUS | 25 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / PERINEURAL | 0.02 %w/v | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION, SOLUTION / INTRAVENOUS | 4050 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION / ORAL | 0.13 mg/5ml | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAVENOUS | 864 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | GRANULE, FOR SUSPENSION / ORAL | 30 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | ELIXIR / ORAL | 90 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAVENOUS | 772 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| saccharin sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, CHEWABLE / ORAL | 84 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 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 |
|---|---|---|---|---|---|---|
| c96c5d9b-5566-4135-9438-0032c4e9b5a0 | a6c6a3f7-0295-4715-9bf8-cfecef7b13e2 | 2011-10-26 | Warnings | c96c5d9b-5566-4135-9438-0032c4e9b5a0 a6c6a3f7-0295-4715-9bf8-cfecef7b13e2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.