XPECT COLD RELIEF- acetaminophen guaifenesein phenylephrine hcl tablet

Xpect Cold Relief by

Drug Labeling and Warnings

Xpect Cold Relief by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, L.N.K. International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Uses

• temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache, nasal congestion, minor aches and pains, sinus congestion and pressure
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 
• temporarily reduces fever

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 

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters, rash, skin reddening. If a skin reaction occurs, stop use and seek medical help right away. 

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. 
• 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 pharmacist before taking this product. 
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• heart disease
• thyroid disease
• diabetes
• liver disease
• high blood pressure
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin. 

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. 

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental 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

• do not take more than directed
• adults and children 12 years and over: take 2 caplets every 4 hours; swallow whole - do not crush, chew, or dissolve; do not take more than 10 caplets in 24 hours 
• children under 12 years: ask a doctor

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see package for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glyvol, polyvinyl alcohol, povidone, silicone dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions? 

1-877-973-2811 Monday-Friday 8:00 AM-5:00 PM

Principal Display - 40 Packets

*compare to the active ingredients in Tylenol® SINUS SEVERE

COLD RELIEF 

Active Ingredients: 

Acetaminophen

Guaifenesin

Phenylephrine HCl

Pain Reliever/Fever Reducer

Expectorant

Nasal Decongestant 

Xpect® First aid

WORKPLACE READY®

• Single Dose
• Tamper Evident 
• Relieves sinus headache, sinus pressure, nasal congestion, mucus, chest congestion

80 Tablets  40 Packets (2 tablets in each packet) per box

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS SEVERE.

INGREDIENTS AND APPEARANCE

XPECT COLD RELIEF 
acetaminophen guaifenesein phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-112-11	80 in 1 BOX	03/29/2021	09/23/2025
1	NDC: 42961-112-10	2 in 1 PACKET; Type 1: Convenience Kit of Co-Package
2	NDC: 42961-112-12	200 in 1 BOX	12/30/2022	09/23/2025
2	NDC: 42961-112-10	2 in 1 PACKET; Type 1: Convenience Kit of Co-Package
3	NDC: 42961-112-13	25 in 1 BAG	09/23/2027
3	NDC: 42961-112-10	2 in 1 PACKET; Type 1: Convenience Kit of Co-Package
4	NDC: 42961-112-14	40 in 1 BOX	09/23/2027
4	NDC: 42961-112-10	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 Drug	M013	03/29/2021

Labeler - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
L.N.K. International		832867837	manufacture(42961-112)