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Pain relief extra strength - Prescription Drug Labeling

Product NDC Code 69168-005
Drug Name

Pain relief extra strength

Type Brand
Active Ingredients
Acetaminophen 500 mg/1
Route ORAL
Dosage Form CAPSULE, COATED
RxCUI drug identifier 198439
Application Number part343
Labeler Name Allegiant Health
Packages
Package NDC Code Description
69168-005-40 1 bottle in 1 carton (69168-005-40) > 40 capsule, coated in 1 bottle

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient(s) Acetaminophen 500 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose Pain reliever/fever reducer

Spl product data elements

Usually a list of ingredients in a drug product.
Pain Relief Extra Strength Pain Relief ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POVIDONE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A CORN AZ328

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Pain Relief Pain Relief Pain Relief Pain Relief

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other information store between 20º-25ºC (68º-77ºF) do not use if imprinted safety seal under cap is broken or missing You may report side effects to 1-888-952-0050

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have liver disease

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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 or breast feeding

Pregnancy or Breast feeding
Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API