SWIFT SINUS PAIN- acetaminophen, phenylephrine hcl tablet 
Honeywell Safety Products USA, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0498-1041 & 0498-1040: Sinus Pain

Active ingredient (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Purpose

Pain relieve/fever reducer

Nasal decongestant

Uses

  • temporarily relieves these symptoms associated with hayfever and other upper respiratory allergies
  • headache
  • sinus congestion and pressure
  • nasal congestion
  • minor aches and pains
  • helps decongest sinus openings and passages

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur

  • if you take more than 4,00 mg acetaminophen in 24 hours, which is the maximum daily amount
  • 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 skin reaction occurs, stop use and seek medical attention right away.

Do not use

  • with any other product 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 inhibiter (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 use.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • pain or nasl congestion get worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

Overdose warning: In case of accidental overdose, getmedical help or contact a Poison Control Center right away. Promt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • do not take morethan directed (see overdose warning)

Adults and children 12 years of age and older: take 2 tablets every 4-6 hours while symptoms persist

  • do not exceed 8 tablets in 24 hours unless directed by a doctor

Children under 12 years: consult a doctor

Other Information

  • store at room temperature 15-30C (59-86F)
  • avoid excessive heat and humidity
  • TAMPER EVIDENT PACKETS - DO NOT USE IF OPEN OR TORN

Inactive ingredients

Inactive Ingredients: FD&C Blue #1, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

1-800-430-5490

MM1 Sinus Pain Hundred Count Label

Sinus Pain

Honeywell Sinus Pain

SWIFT SINUS PAIN 
acetaminophen, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorblue (sky blue) Scoreno score
ShapeROUND (FR40) Size12mm
FlavorImprint Code FR40
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-1040-25250 in 1 BOX04/14/201101/01/2017
1NDC:0498-1040-10100 in 1 BOX
1NDC:0498-1040-012 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0498-1040-50500 in 1 BOX; Type 0: Not a Combination Product04/14/201101/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/14/201101/01/2017
SINUS PAIN 
acetaminophen, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Colorblue (sky blue) Scoreno score
ShapeROUND (FR40) Size12mm
FlavorImprint Code FR40
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-1041-10100 in 1 BOX01/02/2017
1NDC:0498-1041-012 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0498-1041-25250 in 1 BOX01/02/2017
2NDC:0498-1041-012 in 1 PACKET; Type 0: Not a Combination Product
3NDC:0498-1041-50500 in 1 BOX01/02/2017
3NDC:0498-1041-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/02/201712/29/2022
Labeler - Honeywell Safety Products USA, Inc (118768815)

Revised: 1/2024
Document Id: 0eca65ca-54d9-b264-e063-6294a90a5d40
Set id: cd167c7c-2e4a-49b9-9fec-d16c15ec77bf
Version: 13
Effective Time: 20240112
 
Honeywell Safety Products USA, Inc