SINUS RELIEF- acetaminophen, chlorpheniramine maleate, phenylephrine hcl 
Western Family Foods Inc

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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Western Family Sinus Relief DayTime NightTime Drug Facts

Active ingredients (in each caplet) Sinus Congestion & Pain Day

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose (Day)

Pain reliever/fever reducer

Nasal decongestant

Uses (Day)

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
temporarily reduces fever

Active ingredients (in each caplet) Sinus Congestion & Pain Night

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose (Night)

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses (Night)

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
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
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 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 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

DAYTIMEacesulfame 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

Principal Display Panel

See New Warnings

For Adults

ASPIRIN FREE

Sinus Relief

Pain Reliever/Fever Reducer, Nasal Decongestant, Antihistamine†

Headache – Acetaminophen

Sinus Pressure & Nasal Congestion – Phenylephrine HCl

Non-Drowsy

DAYTIME

COOL ICE ® Instant Cooling Sensation CAPLETS

Gluten Free

Actual Size

12 Caplets

Headache – Acetaminophen

Sinus Pressure & Nasal Congestion – Phenylephrine HCl

Runny Nose – Chlorpheniramine Maleate

†Antihistamine in Nighttime Only

NIGHTTIME

COOL ICE ® Instant Cooling Sensation CAPLETS

Gluten Free

Actual Size

8 CAPLETS

COMPARE TO TYLENOL® SINUS CONGESTION & PAIN active ingedients

Western Family Sinus Relief image 1
Western Family Sinus Relief image image 2
Western Family Sinus Relief image image 3
SINUS RELIEF 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-886
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-886-561 in 1 CARTON; Type 0: Not a Combination Product09/22/201112/01/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 BLISTER PACK 12 
Part 24 BLISTER PACK
Part 1 of 2
DAYTIME 
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code L272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/201112/01/2016
Part 2 of 2
NIGHTTIME 
acetaminophen, chlorpheniramine maleate, 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
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorWHITE (off white) Score2 pieces
ShapeCAPSULESize16mm
FlavorImprint Code L476
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/201112/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/201112/01/2016
Labeler - Western Family Foods Inc (192166072)

Revised: 11/2017
 
Western Family Foods Inc