Up and Up Cold Flu Relief Day Night

Manufacturer
Sixarp, LLC
Effective date
2024-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:07:58

Label at a glance#

ProductUp and Up Cold Flu Relief Day Night
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing

Dosage and administration

take only as directed – see Liver warning use dose cup do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL (2 TBSP) every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Storage and handling

each 30 mL dose cup contains: sodium 39 mg store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredients - Nighttime (in each 30 mL dose cup)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Active ingredients - Daytime (in each 15 mL tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose - Daytime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses - Nighttime

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Uses - Daytime

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings - Nighttime

SPL UNCLASSIFIED SECTION

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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

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

Warnings - Daytime

WARNINGS SECTION

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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

Do not use - Nighttime

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.
  • to make a child sleepy
  • if you have ever had an allergic reaction to this product or any of its ingredients

Do not use - Daytime

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 - Nighttime

OTC - ASK DOCTOR SECTION

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

Ask a doctor before use if you have - Daytime

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are - Nighttime

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Ask a doctor or pharmacist before use if you are - Daytime

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product - Nighttime

OTC - WHEN USING SECTION

  • 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

When using this product - Daytime

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if - Nighttime

OTC - STOP USE SECTION

  • 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.

Stop use and ask a doctor if - Daytime

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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

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 - Nighttime

DOSAGE & ADMINISTRATION SECTION

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

adults & children 12 yrs & over

30 mL (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Directions - Daytime

SPL UNCLASSIFIED SECTION

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

adults & children 12 yrs & over

30 mL (2 TBSP) every 4 hrs

children 6 to under 12 yrs

15 mL (1 TBSP) every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information - Nighttime

STORAGE AND HANDLING SECTION

  • each 30 mL dose cup contains: sodium 39 mg
  • store at 20-25°C (68-77°F)

Other information - Daytime

STORAGE AND HANDLING SECTION

  • each tablespoon contains: sodium 7 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients - Nighttime

INACTIVE INGREDIENT SECTION

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Inactive Ingredients - Daytime

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

Call 1-800-910-6874

Principal Display Panel - Daytime

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredients in Vicks® DayQuil® Cold & Flu

cold/flu relief

multi-symptom

day / non-drowsy

pain reliever/fever reducer, cough suppressant, nasal decongestant

acetaminophen – aches/fever

dextromethorphan HBr – cough

phenylephrine HCl – nasal congestion

alcohol free, antihistamine free

DAY

original flavor

Principal Display Panel - Nighttime

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredients in Vicks® NyQuil® Cold & Flu

cold/flu relief

multi-symptom

night

antihistamine, cough suppressant, fever reducer/pain reliever

acetaminophen – aches/fever/sore throat

dextromethorphan HBr – cough

doxylamine succinate – sneezing, runny nose

does not contain pseudoephedrine

ALCOHOL 10%

NIGHT

cherry flavor

TWO – 12 FL OZ (355 mL), TOTAL 24 FL OZ (1.5 pt) (710 mL)

Up and Up Cold/Flu Relief Day Night Image 1
Up and Up Cold/Flu Relief Day Night Image 1
Up & Up Cold/Flu Relief Day Night Image 2
Up & Up Cold/Flu Relief Day Night Image 2
Up & Up Cold/Flu Relief Day Night Image 3
Up & Up Cold/Flu Relief Day Night Image 3

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-00559368-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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
13b9077c-25ef-4d42-e063-6294a90a375a13b8f480-d1a9-d70c-e063-6394a90ab4f42024-03-15WarningsExact identifier
spl id: 13b9077c-25ef-4d42-e063-6294a90a375a
spl set id: 13b8f480-d1a9-d70c-e063-6394a90ab4f4

Reported adverse events (FAERS/openFDA)#

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