FDA Label for Medi-first Extra Strength Non Aspirin
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medi-first Extra Strength Non Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 500 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- minor pain of arthritis
- backache
- the common cold
- toothache
- premenstrual and menstrual cramps
temporarily reduces fever
Warnings
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
contains acetaminophen, ask a doctor or pharmacist.
Otc - Ask Doctor
Ask a doctor before use if
- you are taking the blood thinning drug warfarin
Otc - Stop Use
Stop use and ask a doctor if
- pain gets worse or lasts more than for 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
Directions
- do not use more than directed (see overdose warning)
- take 2 tablets every 6 hours while symptoms last.
- do not take more than 6 tablets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
Adults and children: (12 years and over)
Children under 12 years: Ask a doctor
Other Safety Information
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
Inactive ingredients
corn starch, hypromellose*, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid*, titanium dioxide*
*may contaim
Otc - Questions
Questions or comments? 1-800-634-7680
Package Label.Principal Display Panel
Medique® Extra Strength APAP
Non-Aspirin Tablets
Tabletas sin Aspirina
Pain Reliever/Fever Reducer • Acetaminophen 500 mg
Alivia el Dolor/ Reduce Ia Fiebre • Acetaminofeno 500 mg
This Package is for Households without Young Children.
Este Paquete Para Hogares Sin Ninos Pequenos.
Pull to Open
Tire Para Abrir
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Unitarias
Collect MediBucks
See inside flap for more details
500 Tablets
(250 x 2)
Medi-First® Extra Strength Non-Aspirin
Aches, Fever • Acetaminophen 500 mg
Dolores, Fiebre • Acetaminofeno 500 mg
Pain Reliever/Fever Reducer
Alivia el Dolor/ Reduce Ia Fiebre
Compare active ingredient to:
Compare el ingrediente activo con:
Extra Strength Tylenol®
Registered Trademark of McNeil Consumer Products
Marca Registrada de McNeil Consumer Products
This Package is for Households without Young Children.
Este Paquete Para Hogares Sin Ninos Pequenos.
Pull to Open
Tire Para Abrir
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Unitarias
250 Tablets
(125 x 2)
Medi-First® Plus Extra Strength Non-Aspirin
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Pull to Open
This Package is for Households without Young Children.
Compare active ingredient to:
Extra StrengthTylenol®
Registered Trademark of McNeil Consumer Products
Tamper Evident
Unit Dose Packets
100 Tablets
(50 x 2)
* Please review the disclaimer below.