FDA Label for Daytime Nighttime Cold/flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS IN DAYTIME (IN EACH 30 ML)
- ACTIVE INGREDIENTS IN NIGHTTIME (IN EACH 30 ML)
- PURPOSE FOR DAYTIME
- PURPOSE FOR NIGHTTIME
- USES
- WARNINGS
- DO NOT USE
- 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?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Daytime Nighttime Cold/flu Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients In Daytime (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Active Ingredients In Nighttime (In Each 30 Ml)
Acetaminophen 650 mg
Diphenhydramine HCI 25 mg
Phenylephrine HCI 10 mg
Purpose For Daytime
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purpose For Nighttime
Pain reliever/fever reducer
Antihistamine / Cough suppressant
Nasal decongestant
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
- 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
NIGHTTIME
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
- 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.
NIGHTTIME
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
- 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
NIGHTTIME
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
- 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.
NIGHTTIME
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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.
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
DAYTIME
- each 30 mL Contains: sodium 16 mg
- store between 20-25°C (68-77°). Do not refrigerate
- each 30 mL contains: potassium 10 mg
- each 30 mL contains: sodium 14 mg
- store between 20-25°C (68-77°F). Do not refrigerate
NIGHTTIME
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?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
DAYTIME & NIGHTTIME
Compare to the active ingredients in Theraflu® ExpressMax® Daytime & Nighttime Severe Cold & Cough*
Daytime
Severe Cold & Flu
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 & Flu
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
CVS HEALTH Daytime and Nighttime Severe Cold & Flu
* Please review the disclaimer below.