FDA Label for Pain Relief Extra Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- STOP USE AND ASK A DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- STORAGE
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Pain Relief Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Good Sense. 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(S)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Use(S)
temporary relief of minor aches and pains associated with ■ common cold ■ headache ■ toothache ■ muscular aches ■ backache ■ arthritis ■ menstrual cramps ■ and reduction of fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen 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
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If
liver disease
Ask A Doctor Or Pharmacist Before Use If
are taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- symptoms do not improve pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present
- a rare sensitivity reaction occurs
- You may report side effects to 1-888-952-0050
Pregnancy/Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.
Overdose Warning
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get 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.
Directions
■ do not use more than directed (see overdose warning)
■ adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last ■ do not take more than 8 caplets in 24 hours, unless directed by
a doctor ■ do not take for more than 10 days unless directed by a doctor.
■ children under 12 years: ask a doctor
Other Information
■ do not use if imprinted safety seal under cap is broken or missing
Storage
■ store between 20°-25°C (68°-77°F)
Inactive Ingredients
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Principal Display Panel
* Please review the disclaimer below.