Revasol Acetaminophen Suspension Dye Free
- Manufacturer
- Rnv LLC
- Effective date
- 2026-02-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:46:06
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, flavors, glycerin,
purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
OTC - QUESTIONS SECTION
Questions or comments? 1-888-446-4753
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 |
|---|---|---|---|---|---|---|
| 84379-357-16 | Revasol Acetaminophen Suspension Dye Free | 474 mL in 1 BOTTLE | LIQUID | 474 | 1 |
Products#
Every source-derived product name is available through these pages.
- Revasol Acetaminophen Suspension Dye Free
- Acetaminophen
- GLYCERIN
- XANTHAN GUM
- WATER
- CARBOXYMETHYLCELLULOSE SODIUM
- ANHYDROUS CITRIC ACID
- SORBITOL SOLUTION
- SODIUM BENZOATE
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84379-357 | 84379-357-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 Dye Free | ACETAMINOPHEN | Rnv LLC | 4abc07b3-6a27-260f-e063-6394a90a28d6 | 2026-02-13 | Warnings | 84379-357-16 84379-357 84379035716 4abc07b3-6a28-260f-e063-6394a90a28d6 4abc07b3-6a27-260f-e063-6394a90a28d6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
