Active Ingredient (In Each Caplet)
Acetaminophen 650 mg
Acetaminophen 650mg Tablet
FDA Label NDC 81877-850
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Forreal Pharmaceuticals, Llc for the product Acetaminophen 650mg (NDC 81877-850). 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 active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to:
minor pain of arthritis
muscular aches
backache
premenstrual and menstrual cramps
the common cold
headache
toothache
temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 6 caplets 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
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.
Do Not Use
with any other drug 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 You Are
taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
pain gets worse or lasts more than 10 days
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 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 or symptoms.
Directions
do not take more than directed (see overdose warning)
adults |
|
under 18 years of age |
|
Other Information
store at 20-25°C (68-77°F)
do not use if printed foil under cap is broken or missing
meets the requirements of USP Dissolution Test 4
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions Or Comments?
1-877-367-3250
Principal Display Panel
NDC 81877-850-30
Forreal Pharmaceuticals LLC
YOUR SOLUTION TO BETTER HEALTHCARE.
Arthritis Pain
ACETAMINOPHEN
Extended - Release Tablets
Pain reliever/ Fever Reducer
For the Temporary Relief of Minor Arthritis Pain
650 mg
Capsule-Shaped Tablets
30 Caplets
TAMPER EVIDENT: DO NOT
USE IF SAFETY SEAL IS BROKEN
OR MISSING FROM BOTTLE.
Marketed By:
Forreal Pharmaceuticals, LLC
Royal Oak MI 48067
Questions or inquiries call
877-367-3250
Acetaminophen-650.jpg (Acetaminophen 650)
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