Vicks® Nyquil™ Ultra Concentrated Cold & Flu, Liquicaps™

Vicks® Nyquil™ Ultra Concentrated Cold & Flu, Liquicaps™
SPL v13
SPL
SPL Set ID febabad6-0bf0-a3f8-e053-6294a90a3aeb
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (6.25 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Mica Gelatin Sorbitol Lecithin, Soybean Polyvinyl Acetate Phthalate Propylene Glycol Polyethylene Glycol, Unspecified Fd&c Blue No. 1 Glycerin Water Titanium Dioxide Povidone D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: NQ Shape: oval Color: green Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-06

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

• headache

• minor aches & pains

• fever

• runny nose & sneezing

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.

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 every day 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

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

Other Information
  • store at no greater than 25° C
Inactive Ingredients

Inactive Ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, lecithin, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, sorbitol sorbitan solution, titanium dioxide, water

When Using This Product

• do not use more than directed

• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

• pain 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.

Ask A Doctor Before Use If You Have

• liver disease

• glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

Active Ingredients (in Each Liquicap)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Principal Display Panel 48 Liquicaps™

MAX STRENGTH

100% MORE LIQUICAPS†

VICKS®

NyQuil™

ULTRA CONCENTRATED

COLD & FLU

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose

Cough

25% SMALLER*

EASY TO SWALLOW

Nighttime Relief

48 LIQUICAPS™

Ask A Doctor Or Pharmacist Before Use If You Are

• taking sedatives or tranquilizers • taking the blood thinning drug warfarin


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

• headache

• minor aches & pains

• fever

• runny nose & sneezing

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.

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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 every day 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

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

Other Information (Other information)
  • store at no greater than 25° C
Inactive Ingredients (Inactive ingredients)

Inactive Ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, lecithin, mica, polyethylene glycol, polyvinyl acetate phthalate, povidone, sorbitol sorbitan solution, titanium dioxide, water

When Using This Product (When using this product)

• do not use more than directed

• excitability may occur, especially in children

• marked drowsiness may occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• pain 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• liver disease

• glaucoma

• cough that occurs with too much phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

• trouble urinating due to enlarged prostate gland

Active Ingredients (in Each Liquicap) (Active ingredients (in each LiquiCap))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Principal Display Panel 48 Liquicaps™ (PRINCIPAL DISPLAY PANEL - 48 LiquiCaps™)

MAX STRENGTH

100% MORE LIQUICAPS†

VICKS®

NyQuil™

ULTRA CONCENTRATED

COLD & FLU

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose

Cough

25% SMALLER*

EASY TO SWALLOW

Nighttime Relief

48 LIQUICAPS™

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

• taking sedatives or tranquilizers • taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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