CAREONE SINUS RELIEF DAY TIME NIGHT TIME- acetaminophen, guaifenesin, diphenhydramine hydrochloride, phenylephrine hydrochloride 
American Sales Company

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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American Sales Company Sinus Relief Day Time Night Time Drug Facts

Active ingredients (in each caplet) – SINUS RELIEF Day

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) – SINUS RELIEF Night

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purposes – SINUS RELIEF Day

Pain reliever

Expectorant

Nasal decongestant

Purposes – SINUS RELIEF Night

Pain reliever

Antihistamine

Nasal decongestant

Uses

temporarily relieves:
nasal congestion
headache
minor aches and pains
sinus congestion and pressure
runny nose and sneezing (SINUS RELIEF Night only)
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (SINUS RELIEF Day only)

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.
with any other product containing diphenhydramine, even one used on skin (SINUS RELIEF Night only)
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
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
glaucoma (SINUS RELIEF Night only)
a breathing problem such as emphysema or chronic bronchitis (SINUS RELIEF Night only)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS RELIEF Day only)
cough that occurs with too much phlegm (mucus) (SINUS RELIEF Day only)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers (SINUS RELIEF Night only)

When using these products

do not use more than directed
excitability may occur, especially in children (SINUS RELIEF Night only)
marked drowsiness may occur (SINUS RELIEF Night only)
alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS RELIEF Night only)
avoid alcoholic drinks (SINUS RELIEF Night only)
be careful when driving a motor vehicle or operating machinery (SINUS RELIEF Night only)

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain, cough 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
cough comes back or occurs with rash or persistent headache. These could be signs of a serious condition. (SINUS RELIEF Day only)

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 more than 10 caplets in any 24-hour period
adults and children 12 years of age and older: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other information

each caplet contains: sodium 4 mg (SINUS RELIEF Day only)
store at 20-25°C (68-77°F)

Inactive ingredients - SINUS RELIEF Day only

croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive ingredients - SINUS RELIEF Night only

crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMBINATION PACK

Compare to the active ingredients in Mucinex® Sinus-Max® Day

SINUS RELIEF

DAY TIME

Pain Reliever – Acetaminophen

Expectorant – Guaifenesin

Nasal Decongestant – Phenylephrine HCl

Maximum Strength

Relieves Sinus Pressure, Headache & Congestion

Thins & Loosens Mucus

For Ages 12+

See New Warnings

Gluten Free

Actual Size

10 CAPLETS

Compare to the active ingredients in Mucinex® Sinus-Max® Night

SINUS RELIEF

NIGHT TIME

Pain Reliever – Acetaminophen

Antihistamine – Diphenhydramine HCl

Nasal Decongestant – Phenylephrine HCl

Maximum Strength

Relieves Nasal Congestion, Sinus Pressure & Pain

Relieves Runny Nose & Sneezing

For Ages 12+

See New Warnings

Gluten Free

Actual Size

10 CAPLETS

sinus-relief-day-time-night-time-carton-image-1
sinus-relief-day-time-night-time-carton-image-2
CAREONE SINUS RELIEF DAY TIME NIGHT TIME 
acetaminophen, guaifenesin, diphenhydramine hydrochloride, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-936
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-936-801 in 1 CARTON; Type 0: Not a Combination Product08/17/201810/11/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 10 
Part 22 BLISTER PACK 10 
Part 1 of 2
CAREONE SINUS RELIEF DAY TIME 
acetaminophen, guaifenesin, phenylephrine hydrochloride tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
FlavorImprint Code L145
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/17/201810/11/2022
Part 2 of 2
CAREONE SINUS RELIEF NIGHT TIME 
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride tablet, coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code L625
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/17/201810/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/17/201810/11/2022
Labeler - American Sales Company (809183973)

Revised: 11/2021
 
American Sales Company