655L Walgreens Acetaminophen 160 mg suspension Infants
- Manufacturer
- WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-03-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:42:13
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses temporarily:
■ reduces fever
■ relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
WARNINGS SECTION
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.
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product, do not exceed recommended dose (see overdose warning)
OTC - STOP USE SECTION
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:
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.
DOSAGE & ADMINISTRATION SECTION
Directions
Do not take more than directed.
See overdose warning
■
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.
■ push air out of syringe. Insert syringe tip into the bottle opening
■ flip bottle upside down. Pull yellow part of syringe to correct dose
■ dispense liquid slowly into child’s mouth, toward inner cheek
■ repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours
■ replace cap tightly to maintain child
resistance
DOSING CHART
| Weight (lbs) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
*or as directed by a doctor
Attention: use only enclosed syringe specifically designed for use with this product.
Do not use any other dosing device.
OTHER SAFETY INFORMATION
Other information
■
each 5 mL contains: sodium 2 mg
■ store between 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
OTC - QUESTIONS SECTION
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 | 2 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 2 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 2 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 2 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-6555-04 | Infants Pain and Fever | 1 in 1 CARTON | SUSPENSION | 1 | 2 | |
| 0363-6555-04 | Infants Pain and Fever | 60 mL in 1 BOTTLE | SUSPENSION | 60 | 2 |
Products#
Every source-derived product name is available through these pages.
- Infants Pain and Fever
- Acetaminophen
- GLYCERIN
- SUCRALOSE
- FD&C RED NO. 40
- SUCROSE
- SORBITOL SOLUTION
- WATER
- HYDROXYETHYL CELLULOSE, UNSPECIFIED
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- SODIUM BENZOATE
- XANTHAN GUM
- ANHYDROUS CITRIC ACID
- PROPYLPARABEN
- MICROCRYSTALLINE CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-6555 | 0363-6555-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Infants Pain and Fever | ACETAMINOPHEN | WALGREENS | 281a530b-c759-50eb-e063-6394a90abb4f | 2025-03-28 | Warnings | 0363-6555-04 0363-6555 00363655504 31603d4e-735c-67a9-e063-6294a90ac19c 281a530b-c759-50eb-e063-6394a90abb4f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

