Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Childrens Acetaminophen Oral Liquid
- Manufacturer
- AARNA USA INC.
- Effective date
- 2025-07-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:37
Label at a glance#
ProductChildrens Acetaminophen Oral Liquid Grape Flavor
Active ingredientACETAMINOPHEN
Label structure8 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use shake well before using mL = milliliter find right dose on chart below. if possible, use weight to dose, otherwise use age use only the enclosed dosing cup designed for use with product. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours. Weight (lbs) Age (yrs.) Dose (tsp or mL) Weight (...
Storage and handling
Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Active ingredient(in each 5mL)
Purpose
Acetaminophen 160 mg ………………………….........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 your child takes:
- more then 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, persist or 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 nonprescription).
- If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or anyof the inactive ingredients in this product.
Ask a doctor or pharmacist before use if the child has
liver disease.
Ask 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 for more then 5 days
- fever gets worse or last for more then 3 days
- new symptoms occur redness or swelling is present. These could be signs of a serious condition.
Overdose warning:
In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Keep out of Reach of children
Directions
- this product does not contain directions or complete warnings for adult use
- shake well before using
- mL = milliliter
- find right dose on chart below. if possible, use weight to dose, otherwise use age
- use only the enclosed dosing cup designed for use with product.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours.
| Weight (lbs) | Age (yrs.) | Dose (tsp or mL) | Weight (lbs) | Age (yrs.) | Dose (tsp or mL) |
| under 24 | under 2 | ask a doctor | 48 to 59 | 6 to 8 | 2 tsp or 10 mL |
| 25 to 35 | 2 to 3 | 1 tsp or 5 mL | 60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL |
| 36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL | 72 to 95 | 11 | 3 tsp or 15 mL |
Other Information
- Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.
Inactive Ingredients
Anhydrous Citric Acid, D&C Red No 33, FD&C Blue No 1, Glycerin, Grape Flavor, Polyethylene Glycol 400, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.
Questions or comments?
call toll-free 1-877-225-6999
Manufactured for:
AARNA USA INC.
Leland, NC-28451
This product is not manufactured by or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Eixir.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82568-0009-4 | Childrens Acetaminophen Oral LiquidGrape Flavor | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 | |
| 82568-0009-4 | Childrens Acetaminophen Oral LiquidGrape Flavor | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 82568-0009-6 | Childrens Acetaminophen Oral LiquidGrape Flavor | 473 mL in 1 BOTTLE | LIQUID | 473 | 1 | |
| 82568-0009-8 | Childrens Acetaminophen Oral LiquidGrape Flavor | 236 mL in 1 BOTTLE | LIQUID | 236 | 1 | |
| 82568-0009-8 | Childrens Acetaminophen Oral LiquidGrape Flavor | 1 in 1 CARTON | LIQUID | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Childrens Acetaminophen Oral Liquid Grape Flavor
- Acetaminophen
- D&C RED NO. 33
- FD&C BLUE NO. 1
- ANHYDROUS CITRIC ACID
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE
- SORBITOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82568-0009 | 82568-0009-4, 82568-0009-8, 82568-0009-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Childrens Acetaminophen Oral Liquid Grape Flavor | ACETAMINOPHEN | AARNA USA INC. | 39347f5d-2d3c-0c23-e063-6294a90a3a46 | 2025-07-05 | Warnings | 82568-0009-4 82568-0009-6 82568-0009-8 82568-0009 82568000904 82568000906 82568000908 39347f6d-dea6-d2c5-e063-6394a90a54b0 39347f5d-2d3c-0c23-e063-6294a90a3a46 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.