XPECT ACETAMINOPHEN- acetaminophen tablet

Xpect Acetaminophen by

Drug Labeling and Warnings

Xpect Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Pain reliever/Fever reducer

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 attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Active Ingredients

Active ingredient (in each tablet)
Acetaminophen 500mg……………….Pain reliever/Fever reducer

Inactive Ingredients

Corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide. May contain povidone and sodium starch glycolate.

Uses(s)

Temporarily relieves fever and minor aches and pains associated with:
Headache
Common cold
Muscular aches
Backache
Menstrual cramps
Toothache
Minor arthritis pain

Warning(s)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
More than 8 tablets 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Skin reddening
Blisters
Rash
If skin reaction occurs, stop use and seek medical help right away.
Do not use
With any other product containing acetaminophen (prescription or nonprescription)
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 are taking the blood thinning drug warfarin.
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.
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 overdose, get medical help or contact a Poison Control Center right away. Prompt attention is critical for adults as well as 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 concern.

Other Information

Do not use if packet is torn, cut, or opened
Store at room temperature
Avoid excessive heat and humidity
Single Dose
Tamper Evident
Non-Drowsy
Aspirin-free
See new warnings information
Questions? 1-877-973-2811 Monday – Friday 8AM – 5PM
250 Tablets/2 Tablets per Packet
Product #111399

Xpect Acetaminophen

INGREDIENTS AND APPEARANCE

XPECT ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-399
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	POVIDONE (UNII: FZ989GH94E)
May contain	SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-399-02	250 in 1 BOX	03/30/2021
1	NDC: 42961-399-01	2 in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/30/2021

Labeler - Cintas Corporation (056481716)