TOPCARE SINUS CONGESTION AND PAIN- acetaminophen, chlorpheniramine maleate, phenylephrine hcl 
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Topco Sinus Congestion and Pain Drug Facts

Active ingredient (in each caplet) - Nighttime

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever

Antihistamine

Nasal decongestant

Uses - Nighttime

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 - Nighttime

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

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.
to make a child sleepy

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
a breathing problem such as emphysema or chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product

do not use more than directed
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

you get nervous, dizzy or sleepless
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.

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 - Nighttime

do not take more than directed (see Liver warning)
do not take the 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 4-6 hours
swallow whole – do not crush, chew or dissolve

children under 12 years

do not use this adult product in children under 12 years of age

Inactive ingredients - Nighttime

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

Questions or comments? - Nighttime

1-888-423-0139

Active ingredient (in each caplet) - Daytime

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose - Daytime

Pain reliever

Nasal decongestant

Uses - Daytime

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

Warnings - Daytime

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

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.

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy or sleepless
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.

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 - Daytime

do not take more than directed (see Liver warning)
do not take the 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

do not use this adult product in children

under 12 years of age

Inactive ingredients - Daytime

acesulfame potassium, carnauba wax, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide

Questions or comments? - Daytime

1-888-423-0139

Principal Display Panel

See New Warnings Information

Daytime & Nighttime Convenience Pack

Sinus

Congestion & Pain

Pain Reliever/Nasal Decongestant/*Antihistamine

Day

Non-Drowsy

Contains 2 Medicines:

Headache/Acetaminophen

Sinus Pressure/Nasal Congestion – Phenylephrine HCl

Night

*Antihistamine in Nighttime Only

Contains 3 Medicines:

Headache/Acetaminophen

Sinus Pressure/Nasal Congestion – Phenylephrine HCl

Runny Nose – Chlorpheniramine Maleate

Instant Cooling Sensation

Cool Ice®

Actual Size

Compare to Tylenol® Sinus Congestion & Pain Day & Night active ingredients

Sinus Congestion and Pain Carton

Sinus Congestion and Pain Carton

Sinus Congestion and Pain Carton

TOPCARE SINUS CONGESTION AND PAIN 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-886
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-886-041 in 1 KIT; Type 0: Not a Combination Product04/15/200904/15/2009
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
TOPCARE SINUS CONGESTION AND PAIN 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Product Characteristics
ColorWHITE (off white) Score2 pieces
ShapeCAPSULESize16mm
FlavorVANILLAImprint Code L476
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/23/2009
Part 2 of 2
TOPCARE SINUS CONGESTION AND PAIN 
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Product Characteristics
ColorGREENScoreno score
ShapeOVAL (caplet, film-coated) Size16mm
FlavorImprint Code L272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/12/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/15/200904/15/2009
Labeler - Topco Associates LLC (006935977)

Revised: 10/2017
 
Topco Associates LLC