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SINUS CONGESTION AND PAIN RELIEF

Medically reviewed on Feb 19, 2018

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: We Care Distributor Inc.
NDC Code: 70005-012

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.

SINUS CONGESTION AND PAIN RELIEF - Acetaminophen, Guaifenesinand Phenylephrine HCl

Drug Facts

 
 Active Ingredient (in each tablet) Purpose
 Acetaminophen 325 mg Pain reliever/fever reducer
 Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 5 mg

Nasal decongestant

 

Uses
  • for the temporary relief of:
  • headache
  • nasal congestion
  • minor aches and pains
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves nasal congestion due to the common cold and hay fever and other upper respiratory allergies
  • temporarily reduces fever

Warnings

Liver warning:

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (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 monomine 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
  • thyroid disease
  • diabetes
  • high blood pressure
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis,or emphysema
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)

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, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

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: Taking more than the recommended dose (overdose) may cause liver damage. 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
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over: 
  • take 2 tablets every 4 hours
  • swallow whole - do not crush, chew or dissolve

  • do not take more than 10 tablets in 24 hours

  • children under 12 years: ask a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

  • read all product information before using. Keep this box for important information

Inactive ingredients

FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions

Compare to the Active Ingredients in

Tylenol® Sinus Congestion & Pain Severe

Acetaminophen, Guaifenesin and Phenylephrine HCl 325 mg, 200 mg and 5 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Tablets Each

SINUS CONGESTION AND PAIN RELIEF 
acetaminophen, guaifenesin and phenylephrine hcl 325 mg, 200 mg and 5 mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
STARCH, CORN 
POVIDONE 
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize12mm
FlavorImprint CodeFR;14
Contains    
Packaging
#Item CodePackage Description
1NDC:70005-012-2525 POUCH in 1 BOX
12 Tablet, coated in 1 POUCH
2NDC:70005-012-5050 POUCH in 1 BOX
22 Tablet, coated in 1 POUCH
3NDC:70005-012-022 POUCH in 1 POUCH
32 Tablet, coated in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/15/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(70005-012)

 
We Care Distributor Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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