FDA.reportPublic FDA data

up and up nighttime vapor ice cold and flu

Manufacturer
Target Corporation
Effective date
2019-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:13:36

Label at a glance#

Productup and up daytime vapor ice cold and flu nighttime vapor ice cold and flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure17 sections

Indications and uses

temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose

Dosage and administration

• take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

• each 30 mL contains: sodium 42 mg • store at 20-25 ° C (68-77 ° F)

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL) – Night Time

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. 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

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.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • you get nervous, dizzy or sleepless
  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 42 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-888-547-7400

Active ingredients (in each 30 mL) - Day Time

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • headache
  • fever
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • sore throat
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • promotes nasal and/or sinus drainage

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. 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

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.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an 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
  • diabetes
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 41 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-888-547-7400

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredients in Vicks® DayQuil® Severe+ VapoCOOL™

daytime vapor ice™ cold and flu

MAX STRENGTH

acetaminophen (pain reliever/fever reducer)

phenylephrine HCl (nasal decongestant)

dextromethorphan HBr (cough suppressant)

guaifenesin (expectorant)

minor aches and pains, fever

nasal congestion and sinus pressure

cough, chest congestion

ALCOHOL 10%

12 FL OZ (355 mL)

Compare to active ingredients in Vicks® NyQuil® Severe+ VapoCOOL™

value pack

nighttime vapor ice™ cold and flu

MAX STRENGTH

acetaminophen (pain reliever/fever reducer)

phenylephrine HCl (nasal decongestant)

doxylamine succinate (antihistamine)

dextromethorphan HBr (cough suppressant)

minor aches and pains, fever

nasal congestion and sinus pressure

sneezing, runny nose

cough

ALCOHOL 10%

12 FL OZ (355 mL)

daytime vapor ice cold and flu nighttime vapor ice cold and flu image
daytime vapor ice cold and flu nighttime vapor ice cold and flu image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-47711673-477-02
11673-25111673-251-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ALCOHOL3K9958V90MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ALCOHOL3K9958V90MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
59629deb-cfd1-4f66-9d88-39d3ac22d9f0aeebfcb8-e3e0-4894-9355-4ecd069159062022-10-18WarningsExact identifier
spl set id: aeebfcb8-e3e0-4894-9355-4ecd06915906

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.