FDA Label for Maximum Strength Non-aspirin 100

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT (IN EACH TABLETS)
PURPOSE
USE
LIVER WARNING
DO NOT USE
OTC - ASK DOCTOR
OTC - ASK DOCTOR/PHARMACIST
STOP USE AND ASK DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
OVERDOSE WARNING
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
PRINCIPAL DISPLAY PANEL - 100 TABLET BOX
PRINCIPAL DISPLAY PANEL - 250 TABLET BOX

Maximum Strength Non-aspirin 100 Product Label

The following document was submitted to the FDA by the labeler of this product Jhk Inc Dba American Safety & First Aid. 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

Active Ingredient (In Each Tablets)

Acetaminophen 500 mg

Purpose

pain reliever/fever reducer

Use

temporarily relieves fever and minor aches and pains associated with:

headache
backache
muscular aches
minor arthritis pain
common cold
toothaches
menstrual cramps

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

More than 8 tablets (4000mg of acetaminophen) 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

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

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.

Stop Use And Ask 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 breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed; do not exceed 8 tablets in 24 hours, or as directed by a doctor Children under 12 years of age: Do not use this product; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

Other Information

do not use if packet is opened or torn
store at room temperature 59-86℉ (15-30℃)
avoid excessive heat and humidity

Inactive Ingredients

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

Principal Display Panel - 100 Tablet Box

Product #1122

Maximum Strength
Non-Aspirin

Active ingredient:
Acetaminophen

Pain Reliever/Fever Reducer

Temporary relief from minor aches, pain, and fever
Soothes muscles aches and minor arthritis pain
Non-drowsy, aspirin-free formula

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308. 1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.

100 Tablets • 2 Tablets Per Packet

Principal Display Panel - maxnonaspirin 01

Principal Display Panel - 250 Tablet Box

Product #1124