FDA Label for Genexa Acetaminophen Extra Strength
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Genexa Acetaminophen Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Genexa Inc.. 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
Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing.
*This product is not manufactured or distributed by Johnson & Johnson Inc., distributor of Tylenol® Extra Strength Caplets.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30318 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0059-2
Otc - Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 500 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
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
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4,000 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.
Otc - Do Not Use
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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist 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 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 breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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 take more than directed (see Overdose warning)
adults and children 12 years and over
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets 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 Safety Information
Other information
- each caplet contains: calcium 65 mg, sodium 9 mg
- store between 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
acacia gum, agave fiber, agave syrup, calcium carbonate, organic carnauba wax, dextrose, guar gum, maltodextrin, organic palm olein, rice hulls, sodium bicarbonate, organic sunflower lecithin
Otc - Questions
Questions? 1-855-436-3921
Package Label.Principal Display Panel
Genexa®
MEDICINE MADE CLEAN
For Adults
Acetaminophen Extra Strength
Pain Reliever Fever Reducer
How we're different
Made without: FD&C red no. 40 aluminum lake, titanium dioxide, propylene glycol & more!
Compare to active ingredient in Tylenol® Extra Strength Caplets*
100 Caplets 500 mg each
* Please review the disclaimer below.