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Medique at home apap - Medication Information

Product NDC Code 47682-434
Drug Name

Medique at home apap

Type Brand
Active Ingredients
Acetaminophen 325 mg/1
Route ORAL
Dosage Form TABLET, COATED
RxCUI drug identifier 313782
Application Number part343
Labeler Name Unifirst First Aid Corporation
Packages
Package NDC Code Description
47682-434-33 50 packet in 1 box (47682-434-33) / 2 tablet, 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 325 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 tablets every 4 to 6 hours while symptoms last ■ do not take more than 10 tablets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor Children 6 years to under 12 years ■ take 1 tablet every 4 to 6 hours while symptoms last ■ do not take more than 5 tablets in 24 hours ■ do not use for more than 5 days unless directed by a doctor Children under 6 years ask a doctor

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 due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps 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.
Medique at Home APAP Acetaminophen TITANIUM DIOXIDE STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN POVIDONE AZ;234

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.
Mediqque® @ Home APAP Tablets Acetaminophen 325 mg Pain Reliever/Fever Reducer Pull to Open Child-Resistant Packets *not actual size 50 Packets (2 Tablets per Packet) Compare to the active ingredient in Tylenol® Tablets MDQ145B

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 the user has 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 the user is 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. Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information ■ store at room temperature 59º-86ºF (15º-30ºC) ■ TAMPER EVIDENT child resistant packets ■ do not use any opened or torn packets

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-800-634-7680

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 using and ask a doctor if ■ pain gets worse or lasts more than 10 days in adults ■ pain gets worse or lasts more than 5 days in children under 12 years ■ 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
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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 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.

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