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Product NDC Code | 47682-060 | ||||
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Drug Name | Dover aminofen |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET, COATED | ||||
RxCUI drug identifier | 313782 | ||||
Application Number | M013 | ||||
Labeler Name | Unifirst First Aid Corporation | ||||
Packages |
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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 under 12 years: ask a doctor Other information store at room temperature 59°-86°F (15°-30°C) tamper-evident sealed packets do not use any opened or torn packets
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch*, hypromellose, polyethylene glycol, povidone (K-30)*, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide* May contain*
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 minor arthritis pain backache 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.Medi-First Non-Aspirin Acetaminophen HYPROMELLOSE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN POVIDONE K30 STARCH, CORN (White to Off-White) G323 Medique APAP Acetaminophen POVIDONE K30 POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN STEARIC ACID STARCH, CORN HYPROMELLOSE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO (white to Off-White) G323 Medi-First Plus Non-Aspirin Acetaminophen POVIDONE K30 STEARIC ACID STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN SODIUM STARCH GLYCOLATE TYPE A POTATO HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED (White to Off-White) G323 Medique APAP Acetaminophen HYPROMELLOSES POLYETHYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE white ROUND AZ;234 Medi-First Non-Aspirin Acetaminophen SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE HYPROMELLOSES POLYETHYLENE GLYCOL POVIDONE white ROUND AZ;234 MEDI FIRST PLUS Non-Aspirin Acetaminophen HYPROMELLOSES POLYETHYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE white ROUND AZ;234 DOVER AMINOPHEN Acetaminophen STARCH, CORN STEARIC ACID HYPROMELLOSES POLYETHYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE white ROUND AZ;234 Dover Aminofen Acetaminophen SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSE, UNSPECIFIED POVIDONE K30 STEARIC ACID (White to Off-White) G323
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.Medique Apap Medique ® APAP Non-Aspirin Tablets Tabletas sin aspirina Pain Reliever/Fever Reducer • Acetaminophen 325 mg Alivia el Dolor/Reduce la Fiebre • Acetaminofeno 325 mg This Package is For Households Without young Children Este Paquete es Para Hogares sin Ninos Pequenos Pull to Open Tira Para Abrir 500 Tablets (250 x 2) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias 145R APAP 14513 11-6-23 GR 145R APAP 14513 11-6-23 AH
Medi-First Non Aspirin Medi-First ® Non-Aspirin Pain Reliever/Fever Reducer Aches, Fever ● Acetaminophen 325 mg Compare active ingredient to: Tylenol® This Package is For Households Without Young Children Tamper Evident Unit Dose Packets 100 Tablets (50 x 2) 145R 80333 Rev 11-6-23 GR 145R 80333 Rev 11-6-23 AH
Medi-First Plus Non Aspirin Medi First ® Plus Non-Aspirin Acetaminophen 325mg Pull to Open This Package is For Households Without Young Children Pain Reliever/Fever Reducer Compare active ingredient to: Tylenol® Registered Trademark of McNeil Consumer Tamper Evident Unit Dose Packets 100 Tablets (50 x 2's) 145R 90333 Rev 11-6-22 GR 145R 90333 Rev 11-6-23 AH
Dover Aminofen Dover Aminofen Acetaminophen 325 MG Pain Reliever-Fever Reducer This Package is for Households withoutn Young Children. Dover Pharmaceutical Products of the highest quality and effectiveness Tamper Evident Sealed Packets Unit Dose Packs 500 Tablets (250 Packets of 2) All Dover Pharmaceutical formulas conform to federal regulations Antihistamine free No danger of drowsiness Sugar Free for safer use by diabetics Salt free Minimizes high blood pressure Caffeine Free Avoides over stimulation 145R Aminofen 1625303 11-6-23 GR 145R Aminofen 1625303 11-6-23 AH
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. 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 59°-86°F (15°-30°C) tamper-evident sealed 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 and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 4,000 mg 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 using and ask a doctor if pain gets worse and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. 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.
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