Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: -the common cold -flu -headache -sore throat -toothache
SORBITOL SOLUTION
- Manufacturer
- Grocery Outlet, Inc. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2026-04-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:52:28
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 give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child’s dose into the dosing cup repeat dose every 4 hours while symptoms last do not give more than 5 times in ...
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
-
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
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 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 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
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
- 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.
Keep out of reach of children.
.
Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children 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 give more than directed (see overdose warning)
- shake well before using
- mL = milliliter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and squeeze your child’s dose into the dosing cup
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
| Weight (lb) | Age (yr) | Dose (mL)** |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
| 36-47 | 4-5 years | 7.5 mL |
| 48-59 | 6-8 years | 10 mL |
| 60-71 | 9-10 years | 12.5 mL |
| 72-95 | 11 years | 15 mL |
**or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
• each 5 mL contains:
sodium 2 mg
• store between 20-25°C (68-77°F)
Inactive ingredients
anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
Questions or comments?
Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 3 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 3 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 3 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 3 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 3 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 3 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 3 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85828-922-05 | Childrens Acetaminophen | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 3 | |
| 85828-922-05 | Childrens Acetaminophen | 1 in 1 CARTON | SUSPENSION | 1 | 3 |
Products#
Every source-derived product name is available through these pages.
- Childrens Acetaminophen
- Acetaminophen
- SORBITOL SOLUTION
- CARBOXYMETHYLCELLULOSE SODIUM
- XANTHAN GUM
- PROPYLPARABEN
- D&C RED NO. 33
- SUCROSE
- ANHYDROUS CITRIC ACID
- SODIUM BENZOATE
- MICROCRYSTALLINE CELLULOSE
- SUCRALOSE
- HYDROXYETHYL CELLULOSE, UNSPECIFIED
- WATER
- GLYCERIN
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85828-922 | 85828-922-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-02-28 | monthly-update | 2026-06-03 17:58:47 |
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 | ACETAMINOPHEN | Grocery Outlet, Inc. | 44de6f5a-0b5c-6c28-e063-6394a90a7e0b | 2026-04-02 | Warnings | 85828-922-05 85828-922 85828092205 4e77fb9f-bc13-64e1-e063-6394a90af0cd 44de6f5a-0b5c-6c28-e063-6394a90a7e0b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.