Otc - Active Ingredient
Acetaminophen 500mg
Caffeine 65mg
Pain Reliever Plus
FDA Label NDC 73659-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rapid Care, Inc for the product Pain Reliever Plus (NDC 73659-014). 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, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain reliever/fever reducer
Pain reliever aid
Uses
temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Warnings
Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- more than 8 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you
take
Caffeine warning: The recommended dose of this product contains about as much caffeine as
a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while
taking this product because too much caffeine may cause nervousness, irritability,
sleeplessness, and, occasionally, rapid heartbeat.
In case of overdose, get medical help or contact a
Poison Control Center (1-800-222-1222) right away.
Quick medical attention is critical for adults as well
as for children, even if you do not notice any signs
or symptoms.
Otc - Do Not Use
Do not use
- if you are allergic to acetaminophen
- with any other drug containing
- acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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 you are taking the blood thinning drug warfarin
Otc - Stop Use
Stop use and ask a doctor if
- any new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days 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 reach of children.
Directions
- do not use more than directed
- adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours
- children under 12 years: ask a doctor
Other Information
store at 20-25°C (68-77° F)
Inactive Ingredient
corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake,
FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
* Please review the disclaimer below.
