Drug Facts
Active ingredient (in each caplet)
- Acetaminophen 650 mg
Atamel Forte Tablet, Coated
FDA Label NDC 69729-800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Atamel Forte (NDC 69729-800). 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 drug facts, 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.
- Skin redding
- Blisters
- Rash
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- With any other 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 sings of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children
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 sings or symptoms.
Directions
- Do not take more than directed (see overdose warning)
- 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 doctor
- Ask a doctor
Adults | |
| Under 18 years of age |
Other Information
- Store between 20-25°C (60-77°F)
- Do not use if carton is opened.
- Do not use if foil inner seal is broken or missing.
Inactive Ingredients
caranuba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin.
Questions Or Comments?
Call (619)600-5632 (Mon-Fri 9am - 5pm PST)
Other
Made for:
San Diego, CA 92154
Exclusivey distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
Package Label.Principal Display Panel
NDC 69729-800-24
Acetaminophen 650 mg
Atamel®
Via de Administracion: Oral
Forte
Alivia el Dolor
Pain Relief
Reduce la fiebre
Fever Reducer
Dolores Musculares
Muscles Aches
Dolor de cabeza
Headache
Dolor leve por Artritis
Minor Pain of Arthritis
24 Caplets
* Please review the disclaimer below.
