PAIN AND SINUS- acetaminophen and phenylephrine tablet

Pain and Sinus by

Drug Labeling and Warnings

Pain and Sinus by is a Otc medication manufactured, distributed, or labeled by JHK Inc dba American Safety & First Aid, ALLEGIANT HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (In Each Tablet)	Purpose
Acetaminophen 500 mg	pain reliever/fever reducer
Phenylephrine 5 mg	nasal decongestant

Use

temporarily relieves:

• headache
• sinus pain
• nasal and sinus congestion
• minor aches and pains
• fever

Warnings

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 tablets or 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen (prescription or nonprescription)
• 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

• 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product
• for more than 3 days for fever unless directed by a doctor
• with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist
• for more than 10 days for pain unless directed by a doctor

Ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland.

Ask a doctor 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 nasal congestion gets worse or lasts more than 7 days
• pain gets worse or lasts more than 10 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

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and older:

• Take 2 tablets every 6 hours
• do not exceed 8 tablets in 24 hours

Children under 12 years of age: Ask a doctor

Other information

• store at room temperature between 20-25 °C (68-77° F)
• do not use if packet is opened or torn

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box

Product #1192

Pain & Sinus
Reliever

Active ingredient:
Acetaminophen
Phenylephrine

Pain Reliever/Nasal Decongestant

• Formulated for relief from sinus pressure
  and nasal congestion
• Aspirin free non-drowsy formula

These quality comfort tablets are formulated and packaged for use in the workplace
and meet ANSI Z308.1-2021 standards.
They are sealed in tamper evident packets for safety and convenience.

100 Tablets 2 Tablets Per Packet

INGREDIENTS AND APPEARANCE

PAIN AND SINUS 
acetaminophen and phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-1192
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	20mm
Flavor		Imprint Code	AZ261
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73598-1192-1	50 in 1 BOX	05/09/2024
1		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 DRUG	M012	05/09/2024

Labeler - JHK Inc dba American Safety & First Aid (867236309)

Registrant - ALLEGIANT HEALTH (079501930)

Establishment
Name	Address	ID/FEI	Business Operations
ALLEGIANT HEALTH		079501930	MANUFACTURE(73598-1192)