Revasol Acetaminophen Suspension Ndc 84379-311-16

Revasol Acetaminophen Suspension Ndc 84379-311-16
SPL v1
SPL
SPL Set ID 4ab6bb54-7c28-0c6b-e063-6394a90ac4a6
Route
ORAL
Published
Effective Date 2026-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Sorbitol Solution Carboxymethylcellulose Sodium Sucralose Sodium Benzoate Xanthan Gum Glycerin D&c Red No. 33 Water Citric Acid Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

Acetaminophen 160 mg


Medication Information

Warnings and Precautions

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.

Indications and 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

Dosage and 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.

Description

Acetaminophen 160 mg

Section 34088-5

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.

Section 50565-1

Keep out of the reach of children.

Section 50566-9

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.

Section 50567-7

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

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have liver disease

Section 50570-1

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

Section 51727-6

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.

Section 51945-4

Section 53413-1

Questions or comments: 888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 53414-9

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

Section 55105-1

Pain reliever/fever reducer

Section 55106-9

Acetaminophen 160 mg

Section 60561-8

Other Information:

• store between 15-30°C (59-86°F).

• Do not use if printed safety seal is torn, broken or missing.


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

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.

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments: 888-446-4753

Monday - Friday (9 AM - 5 PM EST)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Acetaminophen 160 mg

Section 60561-8 (60561-8)

Other Information:

• store between 15-30°C (59-86°F).

• Do not use if printed safety seal is torn, broken or missing.


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