SINUS PLUS HEADACHE DAY AND NIGHT- acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit

Sinus Plus Headache Day and Night by

Drug Labeling and Warnings

Sinus Plus Headache Day and Night by is a Otc medication manufactured, distributed, or labeled by TopCo Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SINUS CONGESTION & PAIN DAY

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each day caplet)	Purpose
Acetaminophen 325 mg	Pain reliever
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• for the temporary relief of:
  • sinus congestion and pressure
  • headache
  • nasal congestion
  • minor aches and pains
• helps decongest sinus openings and passages
• promotes sinus drainage
• helps clear nasal passages

SPL UNCLASSIFIED SECTION

SINUS CONGESTION & PAIN NIGHT

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each night caplet)	Purpose
Acetaminophen 325 mg	Pain reliever
Chlorpheniramine maleate 2 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• for the temporary relief of:
  • 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

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 caplets 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

• 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

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

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

When using this product

• do not exceed recommended dosage

In addition, when using Sinus Congestion & Pain 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 Day and Night caplets at the same time
• do not take more than a total of 12 caplets in 24 hours

• 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

Other information

• store between 20º-25ºC (68º-77ºF) in a dry place
• retain carton for complete product information

Inactive ingredients

Sinus Congestion & Pain Day

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C blue #1, flavor, hypromellose, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Sinus Congestion & Pain Night

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, flavor, hypromellose, iron oxide ochre, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC: 36800-928-02

For Adults

TopCare® Health™

Sinus + Headache Day + Night

Pharmacists Recommend

Daytime Non-Drowsy

Pain Reliever/Fever Reducer - Acetaminophen

Nasal Decongestant - Phenylephrine HCl

Day Caplet Relieves:

Sinus Headache

Sinus Pressure

Nasal Congestion

12 Cool Taste Caplets

Nighttime

Pain Reliever/Fever Reducer - Acetaminophen

Nasal Decongestant - Phenylephrine HCl

Antihistamine* – Chlorpheniramine Maleate*

Night Caplet Relieves:

Sinus Headache

Sinus Pressure

Nasal Congestion

Runny Nose*

*Antihistamine in Nighttime Only

8 Cool Taste Caplets

INGREDIENTS AND APPEARANCE

SINUS PLUS HEADACHE DAY AND NIGHT 
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-928

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-928-02	1 in 1 CARTON	08/30/2011

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

Part 1 of 2

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 
acetaminophen, and phenylephrine hydrochloride tablet, 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
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	green	Score	no score
Shape	OVAL (capsule-shaped)	Size	17mm
Flavor	MINT	Imprint Code	AAA;1114
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 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

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE 
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, 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
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (Off-White)	Score	no score
Shape	OVAL (capsule-shaped)	Size	17mm
Flavor	MINT	Imprint Code	AAA;1117
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 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	08/30/2011

Labeler - TopCo Associates LLC (006935977)