FDA Label for Dolex Acetaminophen 500mg Extra Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENT & PURPOSE
- OTC - 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
- KEEP OUT OF REACH OF CHILDREN.
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- DISTRIBUTED BY:
- PRINICIPAL DISPLAY PANEL
Dolex Acetaminophen 500mg Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient & Purpose
Otc - Purpose
Active ingredient (in each caplet) | Purpose |
Acetaminophen 500 mg | Pain reliever/ fever reducer |
Uses
For the temporary relief of minor aches and pains due to:
- the common cold
- headache
- backache
- muscular aches
- toothache
- minor pain of arthritis
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000mg in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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 allergic to 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
- redness or swelling is present
- any new symptoms occur
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Overdose Warning:
In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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)
- take 2 caplets, every 6 hours while symptoms last.
- do not take more than
6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days, unless directed by a doctor
- consult a doctor
Age | Dose |
adults and children 12 years of age and over | |
children under 12 years of age |
Other Information
- store at room temperature 77-86°F (25-30°C)
Inactive Ingredients
corn starch,hypromellose,magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k90, stearic acid, titanium dioxide
Distributed By:
PHARMADEL LLC.
New Castle, DE 19720
1-866-359-3478
* Please review the disclaimer below.