NON-DROWSY DAYTIME SEVERE SINUS CONGESTION AND PAIN- acetaminophen, guaifenesin and phenylephrine hcl tablet, film coated 
Spirit Pharmaceuticals LLC

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Non-Drowsy Daytime Severe Sinus Congestion & Pain

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Expectorant
Nasal decongestant

Uses

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • 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, nasal congestion, or cough 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
  • 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.

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

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENTS OF TYLENOL® SINUS SEVERE*

VALUHEALTH

DAYTIME

NON-DROWSY

SEVERE

SINUS

CONGESTION & PAIN

• Acetaminophen - Pain Reliever / Fever Reducer

• Guaifenesin - Expectorant

• Phenylephrine HCl - Nasal Decongestant

Relieves: Sinus headache, nasal congestion, Sinus Pressure, Mucus+Chest Congestion

Carton

NON-DROWSY DAYTIME SEVERE SINUS CONGESTION AND PAIN 
acetaminophen, guaifenesin and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (white to off white) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code S503
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4164-11 in 1 CARTON06/23/2021
112 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/23/2021
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0c02fa25-1eb2-b8da-e063-6394a90af29d
Set id: 9e30efcb-a091-4ec0-8ce3-8136d26cef1c
Version: 4
Effective Time: 20231208
 
Spirit Pharmaceuticals LLC