XPECT PAIN AWAY- pain reliever tablet

Xpect Pain Away by

Drug Labeling and Warnings

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

Drug Details [pdf]

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
hives
facial swelling
asthma (wheezing)
shock
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
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
Do not use:
if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
with any other drug 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
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have asthma
Ask a doctor or pharmacist before use if you are taking:
any other drug containing an NSAID (prescription or nonprescription)
a blood thinning (anticoagulant) or steroid drug
a prescription drug for diabetes, gout, or arthritis
any other drug or are under a doctor’s care for any serious condition
Stop use and ask a doctor if:
an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
feel faint vomit blood have bloody or black stools
have stomach pain that does not get better ringing in the ears or loss of hearing occurs
painful area is red or swollen pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days any new symptoms appear
If pregnant or breast-feeding, ask a health professional before use. It is especially important to not use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

INDICATIONS & USAGE

Temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
sinusitis
toothache
premenstrual & menstrual cramps

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Purposes

Active ingredients (in each tablet)
Acetaminophen 250 mg……………..Pain reliever
Aspirin 250 mg (NSAID)*…………..Pain reliever
Caffeine 65 mg………………………Pain reliever aid

Directions

do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over: take two tablets every 6 hours; not more than 8 tablets in 24 hours
children under 12 years: ask a doctor

ACTIVE INGREDIENT

Acetaminophen 250 mg……………..Pain reliever
Aspirin 250 mg (NSAID)*…………..Pain reliever
Caffeine 65 mg………………………Pain reliever aid
*nonsteroidal anti-inflammatory drug

INACTIVE INGREDIENT

hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

Other Information

store at controlled room temperature 20-25C (68-77F)
read all product information before using. Keep this box for important information.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XPECT PAIN AWAY 
pain reliever tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL METHACRYLATE (UNII: UKW89XAX2X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 250 (UNII: 5246R0812J)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-202-02	100 in 1 BOX	02/27/2021
1	NDC: 42961-202-01	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
ANDA	ANDA075794	02/27/2021

Labeler - Cintas Corporation (056481716)

Registrant - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
UltraTab Laboratories		151051757	manufacture(42961-202)