SWIFT SINUS PAIN- acetaminophen, phenylephrine hcl tablet SINUS PAIN- acetaminophen, phenylephrine hcl tablet

Sinus Pain by

Drug Labeling and Warnings

Sinus Pain by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

MM1

Sinus Pain

INGREDIENTS AND APPEARANCE

SWIFT SINUS PAIN 
acetaminophen, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-1040
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue (sky blue)	Score	no score
Shape	ROUND (FR40)	Size	12mm
Flavor		Imprint Code	FR40
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-1040-25	250 in 1 BOX	04/14/2011	01/01/2017
1	NDC: 0498-1040-10	100 in 1 BOX
1	NDC: 0498-1040-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-1040-50	500 in 1 BOX; Type 0: Not a Combination Product	04/14/2011	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/14/2011	01/01/2017

SINUS PAIN 
acetaminophen, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-1041
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue (sky blue)	Score	no score
Shape	ROUND (FR40)	Size	12mm
Flavor		Imprint Code	FR40
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-1041-10	100 in 1 BOX	01/02/2017
1	NDC: 0498-1041-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-1041-25	250 in 1 BOX	01/02/2017
2	NDC: 0498-1041-01	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0498-1041-50	500 in 1 BOX	01/02/2017
3	NDC: 0498-1041-01	2 in 1 PACKET; 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	01/02/2017

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-1040, 0498-1041)