REVASOL ACETAMINOPHEN SUSPENSION DYE FREE- acetaminophen liquid

Revasol Acetaminophen Suspension Dye Free by

Drug Labeling and Warnings

Revasol Acetaminophen Suspension Dye Free by is a Otc medication manufactured, distributed, or labeled by Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 160 mg

PURPOSE

Pain reliever/fever reducer

INDICATIONS & USAGE

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

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.

DO NOT USE

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

ASK DOCTOR

Ask a doctor before use if you have liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

WHEN USING

When using this product do not exceed recommended dose (see overdose warning)

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

OVERDOSAGE

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

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

Inactive ingredients Anhydrous citric acid, carboxymethylcellulose, flavors, glycerin,
purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

QUESTIONS

Questions or comments? 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVASOL ACETAMINOPHEN SUSPENSION DYE FREE 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-357
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-357-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/01/2025

Labeler - Rnv LLC (118917568)

Registrant - Rnv LLC (118917568)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(84379-357)