FDA Label for Genexa Acetaminophen Pm 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 - WHEN USING
- 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 Pm 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® PM Extra Strength Caplets.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30318 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0063-2
Otc - Active Ingredient
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Otc - Purpose
Purpose
Pain reliever
Nighttime sleep aid
Indications & Usage
Uses
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
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.
- with any other product containing diphenhydramine, even one used on the skin
- in children under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Otc - When Using
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Otc - Stop Use
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
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 at bedtime if needed
- do not take more than 2 caplets in 24 hours, 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 PM Extra Strength
with Diphenhydramine HCl
Pain Reliever Nighttime Sleep Aid
How we're different
Made without: crospovidone, polyethylene glycol, titanium dioxide & more!
Compare to active ingredient in Tylenol® PM Extra Strength Caplets*
100 Caplets
Non-habit forming
* Please review the disclaimer below.