Xpect Sinus Relief by Cintas Corporation Xpect Sinus Relief

Xpect Sinus Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

XPECT SINUS RELIEF- acetaminophen/phenylephrine hcl tablet 
Cintas Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Xpect Sinus Relief

Purpose

Active ingredients (in each tablet)
Acetaminophen 325mg…………….. Internal Analgesic
Phenylephrine HCl 5mg……………Nasal decongestant

Uses

Temporarily relieves:
Sinus pain
Headache
Nasal and sinus congestion
Minor aches and pains

Warnings

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 a skin reaction occurs, stop use and seek medical help right away.
Do Not Use:
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacists before using this product.
For more than 3 days for fever unless directed by a doctor
With any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
For more than 10 days for pain unless directed by a doctor
Ask a doctor before use if you have:
Liver disease
Heart disease
High blood pressure
Thyroid disease
Diabetes
Difficulty in urination due to enlargement of the prostate gland
Ask a doctor before use if you are taking the blood thinning drug warfarin.
When using this product do not exceed recommended dose
Stop use and ask doctor if:
New symptoms occur
Redness or swelling is present
Pain gets worse or lasts for more than 10 days
Fever gets worse or lasts more than 3 days
Nervousness, dizziness, or sleeplessness occurs
If cold gets worse or lasts more than 7 days
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 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: 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 torn, cut or opened
Store at room temperature
Avoid excessive heat and humidity

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.

Acetaminophen 325mg
Phenylephrine HCl 5mg

FD&C Blue #1, Hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid

label-01

XPECT SINUS RELIEF 
acetaminophen/phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42961-206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42961-206-02250 in 1 BOX03/30/2021
1NDC: 42961-206-012 in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/202112/31/2022
Labeler - Cintas Corporation (056481716)
Registrant - Cintas Corporation (056481716)
Establishment
NameAddressID/FEIBusiness Operations
Ultra-Tab Laboratories, Inc.151051757manufacture(42961-206)

Revised: 12/2022
 

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