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#

ProductRevasol Acetaminophen Suspension Dye Free
Active ingredientACETAMINOPHEN
Label structure17 sections

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 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-85 lbs11 years15 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

Acetaminophen susp. dye freeAcetaminophen susp. dye free

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN1
307668acetaminophen 32 MG/ML Oral SuspensionSCD1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY1
307668APAP 32 MG/ML Oral SuspensionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84379-357-16Revasol Acetaminophen Suspension Dye Free474 mL in 1 BOTTLELIQUID4741

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84379-35784379-357-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revasol Acetaminophen Suspension Dye FreeACETAMINOPHENRnv LLC4abc07b3-6a27-260f-e063-6394a90a28d62026-02-13WarningsExact identifier
ndc (package): 84379-357-16
ndc (product): 84379-357
ndc11 (package): 84379035716
spl id: 4abc07b3-6a28-260f-e063-6394a90a28d6
spl set id: 4abc07b3-6a27-260f-e063-6394a90a28d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.