Vicks ®

Vicks ®
SPL v11
SPL
SPL Set ID 9a106291-edda-2135-e053-2995a90a44fd
Route
ORAL
Published
Effective Date 2025-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Acetaminophen (325 mg) Guaifenesin (200 mg)
Inactive Ingredients
Mannitol Titanium Dioxide Ascorbic Acid Sorbitan Sorbitol Dimethicone Povidone Shellac Fd&c Red No. 40 D&c Red No. 33 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water

Identifiers & Packaging

Pill Appearance
Imprint: VSSC Shape: bullet Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-10

Description

Drug Facts

Purpose

Pain reliever/fever reducer Nasal decongestant Expectorant


Medication Information

Purpose

Pain reliever/fever reducer

Nasal decongestant

Expectorant

Description

Drug Facts

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
Section 34088-5

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.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not use more than directed

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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

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.
Questions?

1-800-362-1683

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

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
Other Information
  • do not exceed 25ºC
Inactive Ingredients

ascorbic acid, D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, shellac, simethicone, sorbitan, sorbitol, titanium dioxide, water

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.

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
Active Ingredients (in Each Liquicap)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Guaifenesin 200 mg

Principal Display Panel 24 Liquicap Carton

VICKS ® SinexSEVERE ALL IN ONE SINUS + MUCUS

Acetaminophen- Pain reliever/Fever Reducer,

Phenylephrine HCl - Nasal Decongestant,

Guaifenesin - Expectorant

  • Sinus Pressure
  • Sinus Headache & Pain
  • Sinus Congestion
  • Thins & Loosens Mucus

NON-DROWSY

24 LiquiCaps™

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

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
Section 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product, do not use more than directed

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever/fever reducer

Nasal decongestant

Expectorant

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

Do Not Use (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.
Questions?

1-800-362-1683

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

Liver Warning: (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
Other Information (Other information)
  • do not exceed 25ºC
Inactive Ingredients (Inactive ingredients)

ascorbic acid, D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, shellac, simethicone, sorbitan, sorbitol, titanium dioxide, water

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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
Active Ingredients (in Each Liquicap) (Active ingredients (in each LiquiCap))

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Guaifenesin 200 mg

Principal Display Panel 24 Liquicap Carton (PRINCIPAL DISPLAY PANEL - 24 LiquiCap Carton)

VICKS ® SinexSEVERE ALL IN ONE SINUS + MUCUS

Acetaminophen- Pain reliever/Fever Reducer,

Phenylephrine HCl - Nasal Decongestant,

Guaifenesin - Expectorant

  • Sinus Pressure
  • Sinus Headache & Pain
  • Sinus Congestion
  • Thins & Loosens Mucus

NON-DROWSY

24 LiquiCaps™

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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