Label: SINUS PLUS HEADACHE DAY AND NIGHT- acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-349-02 - Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 15, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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 - SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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 productAllergy 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 ingredientsAsk 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
■ glaucomaAsk a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizersWhen 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 -
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 hoursadults 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
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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, corn starch, croscarmellose sodium, crospovidone, flavor, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
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PRINCIPAL DISPLAY PANEL
TopCare® health
NDC 36800-349-02
For Adults
Sinus + Headache Day + Night
DAYTIME
NON-DROWSY
PAIN RELIEVER/FEVER REDUCER - ACETAMINOPHEN
NASAL DECONGESTANT - PHENYLEPHRINE HCl
DAY CAPLET RELIEVES:
• Sinus Headache
• Sinus Pressure
• Nasal Congestion
actual size
12 COOL TASTE CAPLETS
NIGHTTIME
PAIN RELIEVER/FEVER REDUCER - ACETAMINOPHEN
NASAL DECONGESTANT - PHENYLEPHRINE HCl
ANTIHISTAMINE* - CHLORPHENIRAMINE MALEATE*
NIGHT CAPLET RELIEVES:
• Sinus Headache
• Sinus Pressure
• Nasal Congestion
• Runny Nose*
*Antihistamine in Nighttime Only
actual size
8 COOL TASTE CAPLETS
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INGREDIENTS AND APPEARANCE
SINUS PLUS HEADACHE DAY AND NIGHT
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-349 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-349-02 1 in 1 CARTON 06/18/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 8 Part 1 of 2 ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, and phenylephrine hydrochloride tablet, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 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 Color green Score no score Shape OVAL (capsule-shaped) Size 17mm Flavor MINT Imprint Code AAA;1123 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 Part 2 of 2 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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) Product Characteristics Color white (Off-White) Score no score Shape OVAL (capsule-shaped) Size 17mm Flavor MINT Imprint Code AAA;1128 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/18/2021 Labeler - TOPCO ASSOCIATES LLC (006935977)