VICKS SINEX SEVERE CONGESTION- acetaminophen, phenylephine hcl, and guaifenesin capsule, liquid filled 
The Procter & Gamble Manufacturing Company

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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VICKS ®
Sinex ™
Severe
Congestion
LiquiCaps

LiquiCaps

Drug Facts

Active ingredients (in each LiquiCap)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Uses

temporarily relieves symptoms due to the common cold (or a cold)

  • minor aches and pains
  • headache
  • fever
  • nasal congestion
  • sinus congestion & pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
  • minor aches and pains
  • headache
  • nasal congestion
  • sinus congestion & pressure

Warnings

Liver warning

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

  • more than 8 LiquiCaps in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy Alert:

acetaminophen may cause severe skin reactions. Symptoms may include:

  • Skin reddening
  • Blisters
  • Rash

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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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, 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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center 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

  • take only as directed
  • do not exceed 8 LiquiCaps per 24 hrs

adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs

children 4 to under 12 yrs ask a doctor

children under 4 yrs do not use

Other information

  • do not exceed 25ºC

Inactive ingredients

ammonium hydroxide, D&C Red No. 33, FD&C Red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, simethicone, sorbitol sorbitan solution, titanium dioxide

Questions?

1-800-362-1683

Made in Canada

DIST. BYPROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 LiquiCap Carton

VICKS®

Sinex

SEVERE

CONGESTION

Acetaminophen

Phenylephrine HCl, Guaifenesin

  • Pain & Headache
  • Sinus Congestion & Pressure
  • Chest Congestion

NON-DROWSY

24 LiquiCaps ™

SSCLC

VICKS SINEX SEVERE  CONGESTION
acetaminophen, phenylephine hcl, and guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-525
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
SHELLAC (UNII: 46N107B71O)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
AMMONIA (UNII: 5138Q19F1X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SORBITOL (UNII: 506T60A25R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColorpinkScoreno score
ShapeBULLETSize16mm
FlavorImprint Code VSSC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-525-242 in 1 CARTON07/10/2018
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 finalpart34107/10/201803/31/2022
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2019
 
The Procter & Gamble Manufacturing Company