Otc - Active Ingredient
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Rnv Llc for the product Revasol Acetaminophen Suspension Dye Free (NDC 84379-357). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg
Pain reliever/fever reducer
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
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
• 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 a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
When using this product do not exceed recommended dose (see overdose warning)
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children.
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.
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 information
• store between 15-30°C (59-86°F).
• Do not use if printed safety seal is torn, broken or missing.
Inactive ingredients Anhydrous citric acid, carboxymethylcellulose, flavors, glycerin,
purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
Questions or comments? 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)
* Please review the disclaimer below.