Active Ingredient (In Each Caplet)
Acetaminophen 650 mg
Acetaminophen
FDA Label NDC 0615-8425
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ncs Healthcare Of Ky, Llc Dba Vangard Labs for the product Acetaminophen (NDC 0615-8425). 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, 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.
- skin reddening
- blisters
- rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
Under 18 Years Of Age
- ask a doctor
Other Information
- store between 20-25°C (68-77°F)
- The FDA approved Dissolution methods differ from USP
Inactive Ingredients
carnauba wax, hydroxyethylcellulose, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, magnesium stearate, microcrystalline cellulose, triacetin, titanium dioxide
Questions Or Comments?
Call 1-877-290-4008
Contains No Aspirin
* Please review the disclaimer below.
