Label: UP AND UP COLD FLU RELIEF DAY NIGHT- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
- NDC Code(s): 59368-005-01
- Packager: Sixarp, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 15, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients - Nighttime (in each 30 mL dose cup)
- Active ingredients - Daytime (in each 15 mL tablespoon)
- Purpose - Nighttime
- Purpose - Daytime
- Uses - Nighttime
- Uses - Daytime
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Warnings - Nighttime
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.
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Warnings - Daytime
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
- 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
- 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
- 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
- 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
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product - Nighttime
- 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 - Nighttime
- 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
- 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
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Directions - Nighttime
- 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
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Directions - Daytime
- 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
- Other information - Daytime
- Inactive ingredients - Nighttime
- Inactive Ingredients - Daytime
- Questions?
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Principal Display Panel - Daytime
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
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Principal Display Panel - Nighttime
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)
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INGREDIENTS AND APPEARANCE
UP AND UP COLD FLU RELIEF DAY NIGHT
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59368-005 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59368-005-01 1 in 1 CARTON; Type 0: Not a Combination Product 08/18/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 355 mL Part 2 1 BOTTLE 355 mL Part 1 of 2 UP AND UP COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate suspensionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color red (Clear/Dark Red) Score Shape Size Flavor CHERRY (Menthol Aroma) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 355 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/22/2011 Part 2 of 2 UP AND UP COLD FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl suspensionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) MENTHOL (UNII: L7T10EIP3A) Product Characteristics Color orange (clear) Score Shape Size Flavor MENTHOL (with fruit) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 355 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/07/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/18/2014 Labeler - Sixarp, LLC (016329513) Establishment Name Address ID/FEI Business Operations Sixarp, LLC 016329513 manufacture(59368-005) , label(59368-005) , pack(59368-005)
