Rx Act sinus congestion and pain

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: H E B
NDC Code: 37808-272

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.

HEB 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

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 Information

GLUTEN FREE

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARNAUBA WAX 
CROSPOVIDONE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVAL (caplet, film-coated) Size16mm
FlavorImprint CodeL272
Contains    
Packaging
#Item CodePackage Description
1NDC:37808-272-622 BLISTER PACK (BLISTER PACK) in 1 CARTON
112 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/29/2007
Labeler - H E B (007924756)

Revised: 09/2009
 
H E B

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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