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Physicianscare non aspirin extra strength - Medication Information

Product NDC Code 0924-0123
Drug Name

Physicianscare non aspirin extra strength

Type Brand
Active Ingredients
Acetaminophen 500 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 198440
Application Number part343
Labeler Name Acme United Corporation
Packages
Package NDC Code Description
0924-0123-00 2 tablet, film coated in 1 packet (0924-0123-00)
0924-0123-01 50 packet in 1 carton (0924-0123-01) / 2 tablet, film coated in 1 packet
0924-0123-02 125 packet in 1 carton (0924-0123-02) / 2 tablet, film coated in 1 packet
0924-0123-03 10 packet in 1 carton (0924-0123-03) / 2 tablet, film coated in 1 packet
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) 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 Adults and children: (12 years and older) take 2 tablets every 6 hours as needed. do not take more than 8 tablets in 24 hours. Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Inactive ingredient

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

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.
Uses temporarily relieves minor aches and pains associated with ■ headache ■ muscular aches ■ minor arthritis pain ■ toothache ■ menstrual cramps ■ common cold temporarily reduces 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.
PhysiciansCare Non Aspirin Extra Strength Acetaminophen HYPROMELLOSES POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN POLYETHYLENE GLYCOL, UNSPECIFIED white ROUND AZ;235

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.
PhysiciansCare XS Non Aspirin Label Physicians Care® Extra Strength Non Aspirin Pain Reliever and Fever Reducer Pull To Open Coated Tablets Individually packaged for workplace use Tamper-Evident Packets of 2 Tablets Do not use if packet is open or torn. Aceatminiphen 500 mg 100 Tablets (50 Packets, 2 tablets each) 90016 Physicians Care

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.
Drug Facts

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. ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor

PhysiciansCare Non Aspirin Extra Strength: Information for patients

Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.
Other information ■ store at room temperature 59º-86ºF (15º-30ºC) ■ do not use any opened or torn packets

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 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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-835-2263

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 ■ symptoms do not improve ■ redness or swelling is present ■ pain or fever persists or gets worse ■ new symptoms occur

Pregnancy or breast feeding

Pregnancy or Breast feeding
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 tablets 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. ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor 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 ■ symptoms do not improve ■ redness or swelling is present ■ pain or fever persists or gets worse ■ new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me 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