SMART SENSE SINUS RELIEF- acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit

smart sense sinus relief by

Drug Labeling and Warnings

smart sense sinus relief by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet) – SINUS RELIEF Day

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) – SINUS RELIEF Night

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purposes – SINUS RELIEF Day

Pain reliever

Expectorant

Nasal decongestant

Purposes – SINUS RELIEF Night

Pain reliever

Antihistamine

Nasal decongestant

Uses

• temporarily relieves:
• nasal congestion
• headache
• minor aches and pains
• sinus congestion and pressure
• runny nose and sneezing (SINUS RELIEF Night only)
• temporarily promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (SINUS RELIEF Day only)

Warnings

Liver warning: These products contain 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 these products

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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• with any other product containing diphenhydramine, even one used on skin (SINUS RELIEF Night only)
• 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 these products.
• if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have

• liver disease
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• glaucoma (SINUS RELIEF Night only)
• a breathing problem such as emphysema or chronic bronchitis (SINUS RELIEF Night only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS RELIEF Day only)
• cough that occurs with too much phlegm (mucus) (SINUS RELIEF Day only)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers (SINUS RELIEF Night only)

When using these products

• do not use more than directed
• excitability may occur, especially in children (SINUS RELIEF Night only)
• marked drowsiness may occur (SINUS RELIEF Night only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS RELIEF Night only)
• avoid alcoholic drinks (SINUS RELIEF Night only)
• be careful when driving a motor vehicle or operating machinery (SINUS RELIEF Night only)

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, cough or nasal congestion 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 persistent headache. These could be signs of a serious condition. (SINUS RELIEF Day only)

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 (see Overdose warning)
• do not take more than 10 caplets in any 24-hour period
• adults and children 12 years of age and older: take 2 caplets every 4 hours
• children under 12 years of age: do not use

Other information

• each caplet contains: sodium 4 mg (SINUS RELIEF Day only)
• store at 20-25°C (68-77°F)

Inactive ingredients - SINUS RELIEF Day only

croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive ingredients - SINUS RELIEF Night only

crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

SEE NEW WARNINGS

COMPARE TO ACTIVE INGREDIENTS IN MUCINEX® SINUS-MAX®

ACTUAL SIZE

daytime

sinus relief

ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCl

PAIN RELIEVER, EXPECTORANT, NASAL DECONGESTANT

MAXIMUM STRENGTH

10 CAPLETS

RELIEVES:

SINUS PRESSURE

HEADACHE – CONGESTION

THINS & LOOSENS MUCUS

nighttime

sinus relief

ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl

PAIN RELIEVER, ANTIHISTAMINE, NASAL DECONGESTANT

MAXIMUM STRENGTH

RELIEVES:

NASAL CONGESTION

SINUS PRESSURE & PAIN

RUNNY NOSE – SNEEZING

10 CAPLETS

INGREDIENTS AND APPEARANCE

SMART SENSE SINUS RELIEF 
acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-936

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-936-80	1 in 1 KIT; Type 0: Not a Combination Product	12/29/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	5 BLISTER PACK	10
Part 2	5 BLISTER PACK	10

Part 1 of 2

SMART SENSE DAYTIME SINUS RELIEF 
acetaminophen, guaifenesin, phenylephrine hcl capsule, coated

Product Information
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	L145
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 in 1 CARTON
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/29/2015

Part 2 of 2

SMART SENSE NIGHTTIME SINUS RELIEF 
acetaminophen, diphenhydramine hcl, phenylephrine hcl capsule, coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	L625
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 in 1 CARTON
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/29/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/29/2015

Labeler - Kmart Corporation (008965873)