HARRIS TEETER SINUS RELIEF- acetaminophen, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride 
Harris Teeter, 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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Harris Teeter, LLC Sinus Relief Drug Facts

Active ingredients (in each caplet) SINUS RELIEF Day

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever

Expectorant

Nasal decongestant

Active ingredients (in each caplet) SINUS RELIEF Night

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever

Antihistamine/cough suppressant

Nasal decongestant

Uses

temporarily relieves:
nasal congestion
headache
minor aches and pains
sinus congestion and pressure
runny nose and sneezing (NIGHT only)
cough (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 (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 (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 (NIGHT only)
a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers (NIGHT only)

When using these products

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

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion or cough 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 headache that lasts. 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 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 (DAY only)
store at 20-25°C (68-77°F)

Inactive ingredients (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 (NIGHT only)

crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 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

Principal Display Panel

Convenience Pack

Maximum Strength

For Ages 12+

Compare to active ingredients in Mucinex® Sinus-Max®

Sinus Relief

Pain Reliever – Acetaminophen

Expectorant – Guaifenesin

Nasal Decongestant – Phenylephrine HCl

DAY TIME

Relieves:

Sinus Pressure

Headache

Congestion

Thins & Loosens Mucus

Actual Size

10 CAPLETS

Pain Reliever – Acetaminophen

Antihistamine/Cough Suppressant – Diphenhydramine HCl

Nasal Decongestant – Phenylephrine HCl

NIGHT TIME

Relieves:

Nasal Congestion

Sinus Pressure & Pain

Runny Nose

Sneezing & Cough

Actual Size

10 CAPLETS

sinus relief image
HARRIS TEETER SINUS RELIEF 
acetaminophen, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69256-040
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69256-040-801 in 1 KIT; Type 0: Not a Combination Product12/17/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 15 BLISTER PACK 10 
Part 25 BLISTER PACK 10 
Part 1 of 2
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
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 finalpart341
Part 2 of 2
SINUS RELIEF NIGHT TIME 
acetaminophen, diphenhydramine hydrochloride, 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
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 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)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
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 L27H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 finalpart341
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/17/2019
Labeler - Harris Teeter, LLC (048463103)

Revised: 1/2020
Document Id: 0c3b66bb-a7d2-4125-9aea-9b089704446c
Set id: 0c3b66bb-a7d2-4125-9aea-9b089704446c
Version: 1
Effective Time: 20200114
 
Harris Teeter, LLC