SINUS PRESSURE PAIN MAXIMUM STRENGTH, NON-DROWSY- acetaminophen, phenylephrine hcl tablet

Sinus Pressure Pain by

Drug Labeling and Warnings

Sinus Pressure Pain by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant 

Uses

• temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
  
  • minor aches and pains
  • nasal congestion 
  • headache
  • sinus congestion and pressure 
• promotes sinus drainage
• temporarily reduces fever 

Warnings

Liver warning: This product contains acetaminophen. 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

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin. 

When using this product

do not exceed recommended dosage. 

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.

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

Directions

• do not use more than directed
• adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not take more than 10 caplets in 24 hours
• children under 12 years: ask a doctor 

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid 

Questions or comments?

1-800-426-9391 

Principal Display Panel

GOOD
NEIGHBOR
PHARMACY®

Compare to SUDAFED PE® PRESSURE + PAIN active ingredients*

NDC: 46122-443-62

MAXIMUM STRENGTH

Sinus Pressure/Pain
acetaminophen, phenylephrine HCl
pain reliever/fever reducer & nasal decongestant

Non-Drowsy

Relief of:
Sinus Headache  Sinus Pressure Nasal Congestion

24 Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed By
Amerisource Bergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com

GOOD NEIGHBOR PHARMACY BRAND PRODUCTS
SATISFACTION GUARANTEED

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN.

50844 ORG041750208

GNP 44-503

INGREDIENTS AND APPEARANCE

SINUS PRESSURE PAIN  MAXIMUM STRENGTH, NON-DROWSY
acetaminophen, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-443
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	44;502
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-443-62	2 in 1 CARTON	06/23/2005
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	06/23/2005

Labeler - Amerisource Bergen (007914906)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(46122-443)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(46122-443)