FDA Label for Revasol Acetaminophen Suspension

Otc - Active Ingredient

Acetaminophen 160 mg

Otc - 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.

Otc - 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

Otc - Ask Doctor

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

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

Otc - 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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

*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, D&C red #33,
FD&C blue #1, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose,
xanthan gum.

Otc - Questions

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