Revasol Acetaminophen Suspension
- Manufacturer
- Rnv LLC
- Effective date
- 2026-02-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:44:15
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
• temporarily: •reduces fever •relieves minor aches and pains due to: • the common
cold • headache • toothache • backache • premenstrual and menstrual cramps • flue • sore
throat • muscular aches • minor pain of arthritis
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult
takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24
hours, which is the maximum daily amount • taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product
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 dug containing acetaminophen (prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are allergic to
acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user 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 10 days in adults • pain
gets worse or lasts more than 5 days in children under 12 years • 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 - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
OVERDOSAGE SECTION
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 of symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions:
•
do not give more than directed (see overdose warning) • shake well
before using • mL=mililiter •
Children 2 years to under 12 years: • find right dose on chart
below: If possible use weight to dose, otherwise, use age • remove the child protective cap and
squeeze the dose into the dosing cup • repeat dose every 4 hours while symtoms last • do not
take more than 5 times in 24 hours unless directed by a doctor • do not take for more than 5
days unless directed by a doctor
| Weight (lb) | Age (years) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
| 36-47 lbs | 4-5 years | 7.5 mL |
| 48-59 lbs | 6-8 years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 72-85 lbs | 11 years | 15 mL |
*or as directed by a doctor
• Adults and children 12 years and over: • take 20 mL (2 x 10 mL) every 4 hours while
symptoms last. For adult dosing, the dosing cup needs to be filled to 10 mL line twice. • do not
take more than 5 doses (100 mL) in 24 hours unless directed by a doctor • do not take for more
than 10 days unless 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 SAFETY INFORMATION
Other Information:
• store between 15-30°C (59-86°F).
• Do not use if printed safety seal is torn, broken or missing.
INACTIVE INGREDIENT SECTION
Inactive ingredients Anhydrous citric acid, carboxymethylcellulose, D&C red #33,
FD&C blue #1, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose,
xanthan gum.
OTC - QUESTIONS SECTION
Questions or comments: 888-446-4753
Monday - Friday (9 AM - 5 PM EST)
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 |
|---|---|---|---|---|---|---|
| 84379-311-16 | Revasol Acetaminophen Suspension | 474 mL in 1 BOTTLE | LIQUID | 474 | 1 |
Products#
Every source-derived product name is available through these pages.
- Revasol Acetaminophen Suspension
- Acetaminophen
- SORBITOL SOLUTION
- CARBOXYMETHYLCELLULOSE SODIUM
- SUCRALOSE
- SODIUM BENZOATE
- XANTHAN GUM
- GLYCERIN
- D&C RED NO. 33
- WATER
- CITRIC ACID
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84379-311 | 84379-311-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| WATER | 059QF0KO0R | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
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 |
|---|---|---|---|---|---|---|
| Revasol Acetaminophen Suspension | ACETAMINOPHEN | Rnv LLC | 4ab6bb54-7c28-0c6b-e063-6394a90ac4a6 | 2026-02-13 | Warnings | 84379-311-16 84379-311 84379031116 4ab6bb54-7c29-0c6b-e063-6394a90ac4a6 4ab6bb54-7c28-0c6b-e063-6394a90ac4a6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
