GOOD NEIGHBOR PHARMACY SINUS CONGESTION AND PAIN- acetaminophen, phenylephrine hcl tablet, film coated 
Amerisource Bergen

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.

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Amerisource Bergen Sinus Congestion & Pain Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

Uses

•
for the temporary relief of:
•
headache
•
sinus congestion and pressure
•
nasal congestion
•
minor aches and pains
•
helps decongest sinus openings and passages
•
promotes sinus drainage
•
helps clear nasal passages

Warnings

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

•
more than 12 caplets 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

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.

Ask 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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

•
you get nervous, dizzy or sleepless
•
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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

•
do not take more than directed (see Liver warning)

adults and children 12 years and over
•
take 2 caplets every 4 hours
•
swallow whole – do not crush, chew or dissolve
•
do not take more than 12 caplets in 24 hours

children under 12 years

do not use this adult product in children under

12 years of age

Inactive ingredients

acesulfame potassium, carnauba wax, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings Information

Compare to Active Ingredients in Tylenol® Sinus Congestion & Pain Daytime

Sinus

Congestion & Pain

Pain Reliever, Nasal Decongestant

Contains 2 Medicines:

Headache – Acetaminophen

Sinus Pressure, Nasal Congestion – Phenylephrine HCl

Cool Ice®

Instant Cooling Sensation

Daytime

Non-Drowsy

Sinus Congestion & Pain Carton Image 1

Sinus Congestion & Pain Carton Image 1

Sinus Congestion & Pain Carton Image 2

Sinus Congestion & Pain Carton Image 1

Sinus Congestion & Pain Carton Image 2

GOOD NEIGHBOR PHARMACY SINUS  CONGESTION AND PAIN
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-169
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREENScoreno score
ShapeOVAL (caplet, film-coated) Size16mm
FlavorImprint Code L272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-169-622 in 1 CARTON12/27/200603/23/2013
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/27/200603/23/2013
Labeler - Amerisource Bergen (007914906)

Revised: 11/2017
Document Id: d6141bcd-b4d7-4dd0-9efd-c2feb01c19a7
Set id: fe2205b7-c0fc-4fc8-9dda-497dd7ec10f2
Version: 2
Effective Time: 20171125
 
Amerisource Bergen