Label: EQUATE NITETIME DAYTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
- NDC Code(s): 49035-733-02
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 9, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Nighttime Cold & FluActive ingredients (in each 30 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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.
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Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Daytime Cold & FluActive ingredients (in each 15 mL)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
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- adult takes more than 4,000 mg of acetaminophen in 24 hours
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- child takes more than 5 doses in 24 hours
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- taken with other drugs containing acetaminophen
- •
- adult has 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
- •
- 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
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- liver disease
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- heart disease
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- thyroid disease
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- diabetes
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- high blood pressure
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
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- you get nervous, dizzy or sleepless
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- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition
- Directions
- Other information
- Inactive Ingredients - Daytime
- Questions or comments?
-
Principal Display Panel
SEE NEW WARNINGS
Compare to DayQuil® Cold & Flu & NyQuil® Cold & Flu Active Ingredients
Non-Drowsy
DayTime
Cold & Flu
Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant
Multi-Symptom Relief
Aches, fever – Acetaminophen
Cough – Dextromethorphan HBr
Nasal congestion – Phenylephrine HCl
Alcohol Free and Antihistamine Free
12 FL OZ (355mL)
SEE NEW WARNINGS
Compare to DayQuil® Cold & Flu & NyQuil® Cold & Flu Active Ingredients
NiteTime
Cold & Flu
Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine
Multi-Symptom Relief
Aches, fever – Acetaminophen
Cough – Dextromethorphan HBr
Sneezing, runny nose – Doxylamine Succinate
10% ALCOHOL
12 FL OZ (355mL)
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INGREDIENTS AND APPEARANCE
EQUATE NITETIME DAYTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-733 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-733-02 1 in 1 CARTON; Type 0: Not a Combination Product 08/15/2013 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 EQUATE NITETIME
acetaminophen, dextromethorphan hbr, doxylamine succinate solutionProduct 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 final part341 08/02/2011 Part 2 of 2 EQUATE DAY TIME COLD AND FLU MULTI SYMPTOM RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl solutionProduct 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 (UNII: 3980JIH2SW) 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 final part341 06/08/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/15/2013 Labeler - Wal-Mart Stores Inc (051957769)