Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
CHILDRENS ACETAMINOPHEN
- Manufacturer
- AARNA USA INC.
- Effective date
- 2025-06-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:03:36
Label at a glance#
ProductCHILDRENS ACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure8 sections
Dosage and administration
This product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL=milliliter find the right dose on chart below. If possible, use weight to dose; otherwise, use age. 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) under 24 under 2 ask a doctor ...
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
- do not give more than directed (see overdose warning)
- shake well before using
- mL=milliliter
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- 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) |
under 24 | under 2 | ask a doctor |
24 to 35 | 2 to 3 | 1 tsp or 5 mL |
36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL |
48 to 59 | 6 to 8 | 2 tsp or 10 mL |
60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL |
72 to 95 | 11 | 3 tsp or 15 mL |
*or as directed by a doctor
- Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
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 #33, FD&C Blue #1, Grape Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.
Questions or comments?
Call toll-free 1-877-225-6999
Manufactured for:
AARNA USA INC.
Leland, NC-28451
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 1 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 1 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 1 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82568-0010-2 | CHILDRENS ACETAMINOPHEN | 60 mL in 1 BOTTLE | SUSPENSION | 60 | 1 | |
| 82568-0010-4 | CHILDRENS ACETAMINOPHEN | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 1 | |
| 82568-0010-6 | CHILDRENS ACETAMINOPHEN | 473 mL in 1 BOTTLE | SUSPENSION | 473 | 1 | |
| 82568-0010-8 | CHILDRENS ACETAMINOPHEN | 236 mL in 1 BOTTLE | SUSPENSION | 236 | 1 |
Products#
Every source-derived product name is available through these pages.
- CHILDRENS ACETAMINOPHEN
- CHILDRENS ACETAMINOPHEN ORAL
- ANHYDROUS CITRIC ACID
- D&C RED NO. 33
- FD&C BLUE NO. 1
- GLYCERIN
- MICROCRYSTALLINE CELLULOSE
- CARBOXYMETHYLCELLULOSE SODIUM
- POTASSIUM SORBATE
- WATER
- SORBITOL
- SUCRALOSE
- SUCROSE
- XANTHAN GUM
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82568-0010 | 82568-0010-2, 82568-0010-4, 82568-0010-8, 82568-0010-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | 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 | CHILDRENS ACETAMINOPHEN ORAL | AARNA USA INC. | 38070d15-2678-4e59-e063-6294a90ab690 | 2025-06-20 | Warnings | 82568-0010-6 82568-0010-4 82568-0010-8 82568-0010-2 82568-0010 82568001004 82568001008 82568001002 82568001006 38070d2d-e016-7d5c-e063-6394a90a71ac 38070d15-2678-4e59-e063-6294a90ab690 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.