Sinus and Headache Day Night by GOODSENSE GDS-1149B-2020-0820

Sinus and Headache Day Night by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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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GDS-1149B-2020-0820

SINUS + HEADACHE DAY

Drug Facts

Active ingredients (in each day caplet)  Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Phenylephrine HCl 5 mgNasal decongestant

Uses

■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
   ■ 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   

SINUS + HEADACHE NIGHT

Drug Facts

Active ingredients (in each night caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
   ■ headache
   ■ sinus congestion and pressure
   ■ nasal congestion
   ■ runny nose and sneezing
   ■ minor aches and pains
■ helps decongest sinus openings and passages
■ promotes sinus drainage
■ helps clear nasal passages
■ temporarily reduces fever

Warnings

Liver warning

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 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
■ 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 this product

do not exceed recommended dosage
In addition, when using Sinus + Headache 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 10 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 20-25ºC (68-77ºF) in a dry place
■ retain carton for complete product information and warnings

Inactive ingredients

SINUS + HEADACHE DAY

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

SINUS + HEADACHE NIGHT

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, flavor, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

GOODSENSE®

NDC: 50804-149-02

Pain Relief

Sinus + Headache

Cool Taste Instant Cooling Sensation

For Adults

Acetaminophen/ Pain RelieverFever Reducer 

Phenylephrine HCl/Nasal Decongestant

Chlorpheniramine Maleate*/Antihistamine*

Day

Sinus Headache

Sinus Pressure

Nasal Congestion

Actual Size

12 CAPLETS

Night

Sinus Headache

Sinus Pressure

Nasal Congestion

Runny Nose*

*antihistamine in Nighttime Only

Actual Size

8 CAPLETS image description

SINUS AND HEADACHE DAY NIGHT 
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50804-149
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50804-149-021 in 1 CARTON08/01/202008/31/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK
Part 1 of 2
ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 
acetaminophen, and 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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVAL (capsule-shaped) Size17mm
FlavorMINTImprint Code AAA;1123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 finalpart341
Part 2 of 2
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE 
acetaminophen, chlorpheniramine maleate, and 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
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (Off-White) Scoreno score
ShapeOVAL (capsule-shaped) Size17mm
FlavorMINTImprint Code AAA;1128
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 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 finalpart34108/01/202008/31/2023
Labeler - GOODSENSE (076059836)

Revised: 12/2022

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