Label: DAYTIME NIGHTTIME COLD/FLU- acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hci kit
- NDC Code(s): 59779-686-16, 59779-691-08, 59779-693-08
- Packager: CVS Pharmacy
- 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 June 27, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients in Daytime (in each 30 mL)
- Active ingredients in Nighttime (in each 30 mL)
- Purpose for Daytime
- Purpose for Nighttime
-
Uses
DAYTIME
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- headache
- nasal and sinus congestion
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
NIGHTTIME
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- headache
- sore throat
- runny nose
- sneezing
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- itchy of the nose or throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
- temporarily relieves these symptoms due to a cold
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Warnings
DAYTIME and NIGHTTIME
Liver warning: These products contain 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
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, ot 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.
NIGHTTIME
- to make a child sleepy
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on the skin
- 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.
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 such as occurs with smoking, asthma, or emphysema
NIGHTTIME
- liver disease
- glaucoma
- high blood pressure
- heart disease
- diabetes
- thyroid disease
- a breathing problem such as emphysema or chronic bronchitis
- 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, or emphysema
Ask a doctor or pharmacist before use if you are
DAYTIME
taking the blood thinning drug warfarin
NIGHTTIME
- the blood thinning drug warfarin
- sedative or tranquilizers
When using this product,
DAYTIME
do not exceed recommended dosage.NIGHTTIME
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- marked drowsiness may occur
- excitability may occur, especially in children
Stop use and ask a doctor if
DAYTIME
- nervousness, dizziness or sleeplessness occur
- pain, cough,or nasal congestion 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.
NIGHTTIME
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Keep out of reach of children.
DAYTIME and NIGHTTIME
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
DAYTIME and NIGHTTIME
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses (180 mL) in any 24-hour peroid
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
- adults and children 12 years and over:
- children under 12 years: do not use
- Other information
-
Inactive ingredients
DAYTIME
acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
NIGHTTIME
acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
- Questions or comments?
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Principal Display Panel
DAYTIME & NIGHTTIME
Compare to the active ingredients in Theraflu® ExpressMax® Daytime & Nighttime Severe Cold & Cough*
Daytime
Severe Cold & Cough
ACETAMINOPHEN
Pain reliever; fever reducer
DEXTROMETHORPHAN HBr
Cough suppressant
PHENYLEPHRINE HCI
Nasal decongestant
Relief of:
Nasal congestion; Cough; Fever; Body ache; Sore Throat; Headache
Berry Flavor
Alcohol content 10%
For Ages 12 & Over
Nighttime
Severe Cold & Cough
ACETAMINOPHEN
Pain reliever; Fever reducer
DIPHENHYDRAMINE HCI
Anthihistamine; Cough suppressant
PHENYLEPHRINE HCI
Nasal decongestant
Relief of:
Nasal congestion; Cough; Fever; Body ache; Sore throat; Headache
Dosing Cup Included
Berry Flavor
Alcohol content 10%
for Ages 12 & Over
FL OZ (mL)
*This product is not manufactured or distributed by GSK Comsumer Healthcare, distributor of Theraflu® ExpressMax® Daytime & Nighttime Severe Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com® 1-800-SHOP CVS
- Product Label
- Product label Daytime
- Package label Nighttime
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD/FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hci kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-686 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-686-16 1 in 1 KIT; Type 0: Not a Combination Product 07/31/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 245 mL Part 2 1 BOTTLE, PLASTIC 245 mL Part 1 of 2 DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Item Code (Source) NDC:59779-691 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 20 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-691-08 245 mL in 1 BOTTLE, PLASTIC; 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 07/31/2016 Part 2 of 2 NIGHTTIME COLD AND FLU
acetaminophen, diphenhydramine hci, phenylephrine hci liquidProduct Information Item Code (Source) NDC:59779-693 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 DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-693-08 245 mL in 1 BOTTLE, PLASTIC; 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 07/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/31/2016 Labeler - CVS Pharmacy (062312574)
