FDA Label for Extra Strength Acetaminohpen Adult Rapid Burst Cherry
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Extra Strength Acetaminohpen Adult Rapid Burst Cherry Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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.
Active Ingredients
Acetaminophen 500 mg
Purpose
Pain reliever/Fever reducer
Uses
- temporarily relieves minor aches and pains due to
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000 mg of acetaminophen in 24 hours
- 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.
Do Not Use
with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist
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 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- do not take more than 4 doses in any 24 hour period
- measure only with dosing cup provided. Do not use any other dosing device
- mL=milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 6 hours while symptoms last
- do not take more than 10 days unless directed by a doctor
- children under 12 years: do not use
Other Information
- each 15 mL contains: sodium 6 mg
- store between 20-25°C (68-77°F). DO not refrigerate
- protect from light
Inactive Ingredients
citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol
Principal Display Panel
Major Mapap
Extra Strength Actetaminophen 500 mg
Rapid Burst
Pain reliever
fever reducer
*COmpare to Extra strength Tylenol® active ingredient
Alcohol free
Cherry
FL OZ (mL)
Questions or comments?
Call 1-877-753-3935
Monday-Fridat 9AM-5PM EST
Distributed by: MAjor Pharmaceuticals
31778 Enterprise Drive, Livonia, MI 48150 USA
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSSING.
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®
Package Label
* Please review the disclaimer below.