Revasol Acetaminophen Suspension Ndc 84379-311-16
4ab6bb54-7c28-0c6b-e063-6394a90ac4a6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-03-06T01:27:29.295580 · Updated: 2026-03-14T23:13:42.453292