RX ACT SINUS CONGESTION AND PAIN- acetaminophen, phenylephrine hcl tablet, film coated 
H E B

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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HEB Sinus Congestion & Pain Drug Facts

Active ingredients (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. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

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

•
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 exceed recommended dosage

Stop use and ask a doctor if

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

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 10 caplets in 24 hours

children under 12 years

ask a doctor

Inactive ingredients

acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® Sinus Congestion & Pain active ingredients

SINUS CONGESTION & PAIN

Daytime Non-Drowsy

Acetaminophen - Phenylephrine HCl

Pain Reliever - Nasal Decongestant

Headache Pain

Sinus Pressure

Nasal Congestion

Instant Cooling Sensation

Cool Ice® Caps

ACTUAL SIZE

See New Warnings and Directions

GLUTEN FREE

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

RX ACT SINUS CONGESTION AND PAIN 
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-272
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:37808-272-622 in 1 CARTON01/29/200712/11/2013
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 finalpart34101/29/200712/11/2013
Labeler - H E B (007924756)

Revised: 11/2017
Document Id: e472ac6e-303a-4265-9914-1d34c5f6e5c0
Set id: 880d332e-5eb8-4c66-9041-76aa6949a1d7
Version: 2
Effective Time: 20171120
 
H E B