FDA Label for Pain Relief Extra Strength
View Indications, Usage & Precautions
Pain Relief Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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
- 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
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
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.
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 use more than 10 days unless directed by a doctor
■ children under 12 years: ask a doctor
Other Information
- store between 20°-25°C (68°-77°F)
- do not use if imprinted safety seal under cap is broken or missing
- You may report side effects to 1-888-952-0050
Inactive Ingredients
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
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