| NDC | 49738-711-56 |
| Set ID | 91168e94-8281-42de-bfc8-84028a5b72de |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)–Sinus + Headache Day
- Active ingredients (in each caplet) - Sinus + Headache Night
- Purpose – Sinus + Headache Day
- Purpose - Sinus + Headache Night
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Uses - Sinus + Headache Day
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- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
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- headache
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- sinus congestion and pressure
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- nasal congestion
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- minor aches and pains
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- helps decongest sinus openings and passages
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- promotes sinus drainage
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- helps clear nasal passages
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- temporarily reduces fever
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Uses – Sinus + Headache Night
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- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
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- headache
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- sinus congestion and pressure
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- nasal congestion
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- runny nose and sneezing
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- minor aches and pains
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- reduces swelling of nasal passages
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- helps decongest sinus openings and passages
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- temporarily reduces fever
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Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using these products
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if you have ever had an allergic reaction to these products or any of their ingredients
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
In addition, when using Sinus + Headache Night:
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- a breathing problem such as emphysema or chronic bronchitis
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- glaucoma
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using these products
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- do not exceed recommended dosage
In addition, when using Sinus + Headache Night:
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- excitability may occur, especially in children
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- drowsiness may occur
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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Directions
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- do not take more than directed (see overdose warning)
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- do not take the Day and Night caplets at the same time
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- do not take more than a total of 10 caplets in 24 hours
DAYTIME
adults and children 12 years and over
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- take 2 caplets every 4 hours
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- swallow whole – do not crush, chew or dissolve
children under 12 years
ask a doctor
NIGHTTIME
adults and children 12 years and over
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- take 2 caplets every 4-6 hours
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- swallow whole – do not crush, chew or dissolve
children under 12 years
ask a doctor
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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?
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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
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INGREDIENTS AND APPEARANCE
SMART SENSE SINUS PLUS HEADACHE
acetaminophen, phenylephrine hcl, chlorpheniramine maleate kitProduct 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 coatedProduct 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 tabletProduct 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)
