SMART SENSE SINUS PLUS HEADACHE- acetaminophen, phenylephrine hcl, chlorpheniramine maleate kit

Smart Sense sinus plus headache by

Drug Labeling and Warnings

Smart Sense sinus plus headache 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 + Headache Day

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) - Sinus + Headache Night

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose – Sinus + Headache Day

Pain reliever/fever reducer

Nasal decongestant

Purpose - Sinus + Headache Night

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses - Sinus + Headache Day

• temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
• headache
• sinus congestion and pressure
• nasal congestion
• minor aches and pains
• helps decongest sinus openings and passages
• promotes sinus drainage
• helps clear nasal passages
• temporarily reduces fever

Uses – Sinus + Headache Night

• temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
• headache
• sinus congestion and pressure
• nasal congestion
• runny nose and sneezing
• minor aches and pains
• reduces swelling of nasal passages
• helps decongest sinus openings and passages
• temporarily reduces fever

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.
• 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
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

In addition, when using Sinus + Headache Night:

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using these products

• do not exceed recommended dosage

In addition, when using Sinus + Headache Night:

• excitability may occur, especially in children
• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain 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

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: 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 the Day and Night caplets at the same time
• do not take more than a total of 10 caplets in 24 hours

DAYTIME

• adults and children 12 years and over:
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve
• children under 12 years:

  ask a doctor

NIGHTTIME

• adults and children 12 years and over:
  • take 2 caplets every 4-6 hours
  • swallow whole – do not crush, chew or dissolve
• children under 12 years:

  ask a doctor

Inactive ingredients

DAYTIME acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

NIGHTTIME acesulfame potassium, carnauba wax, flavor, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

ACTUAL SIZE

sinus + headache day

ACETAMINOPHEN, PHENYLEPHRINE HCl

PAIN RELIEVER / FEVER REDUCER, NASAL DECONGESTANT

NON-DROWSY

FOR ADULTS

RELIEVES:

SINUS HEADACHE

NASAL CONGESTION

SINUS PRESSURE

12 CAPLETS

COMPARE TO ACTIVE INGREDIENTS IN TYLENOL® SINUS + HEADCHE

ACTUAL SIZE

sinus + headache night

ACETAMINOPHEN, PHENYLEPHRINE HCl, CHLORPHENIRAMINE MALEATE

PAIN RELIEVER/FEVER REDUCER, NASAL DECONGESTANT, ANTIHISTAMINE

FOR ADULTS

RELIEVES:

SINUS HEADACHE

NASAL CONGESTION

SINUS PRESSURE

RUNNY NOSE

8 CAPLETS

INGREDIENTS AND APPEARANCE

SMART SENSE SINUS PLUS HEADACHE 
acetaminophen, phenylephrine hcl, chlorpheniramine maleate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-711

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-711-56	1 in 1 KIT; Type 0: Not a Combination Product	06/05/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 BLISTER PACK	12
Part 2	4 BLISTER PACK	8

Part 1 of 2

SMART SENSE SINUS PLUS HEADACHE 
acetaminophen, phenylephrine hcl tablet, film 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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE (caplet, film coated)	Size	16mm
Flavor	VANILLA (menthol)	Imprint Code	L272
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 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

Part 2 of 2

SMART SENSE SINUS PLUS HEADACHE 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

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
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	WHITE (off white)	Score	2 pieces
Shape	CAPSULE	Size	16mm
Flavor	VANILLA	Imprint Code	L476
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/05/2017

Labeler - Kmart Corporation (008965873)