FDA Label for Pain Terminator Extra Strength Pain Relief
View Indications, Usage & Precautions
Pain Terminator Extra Strength Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Wildman Business Group. 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
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
Purpose
Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aid
Indications & Usage
Uses
temporarily relieves minor aches and pains due to
- headache
- muscular aches
- arthritis pain
- a cold
- toothache
- premenstrual and menstrual cramps
Warnings
Warnings
Other
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
- more than 8 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
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat
Do Not Use
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 ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/ fever reducers
Ask Doctor
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have a history of stomach problems such as heartburn
- you have asthma
- you have liver disease
Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for gout, diabetes, or arthritis
- taking any other drug, or under a doctor's care for any serious condition
Stop Use
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- ringing in the ears or loss of hearing occurs
- painful area is red or swollen
- any new symptoms appear
These could be signs of a serious condition.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
- do not use more than directed
- drink a full glass of water with each dose
Adults and children: (12 years and over) Take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours
Children under 12 years: Ask a doctor
Other Safety Information
Other information
- read all product information before using. Keep box for important information.
- store at room temperature 68°-77°F (20°-25°C)
- avoid excessive heat and humidity
- tamper evident sealed packets
- do not use any opened or torn packets
- each caplet contains: Magnesium 0.58 mg
Inactive Ingredient
Inactive ingredients
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc
Questions
Questions or comments? (888) 602-0288
Principal Display Panel – 100 Caplet Box Label
2533
PAIN TERMINATOR
Advanced Severe Pain Formula
Pull to Open
Fast Relief of:
- Headaches
- Muscle Aches
- Back Aches
- Arthritis Pain
The Provision
First Aid
Line™
BY WILDMAN
100 Caplets
2 Per Packet
* Please review the disclaimer below.
