FDA Label for Cvs Dt And Nt Combo Pack Cold And Flu

View Indications, Usage & Precautions

Cvs Dt And Nt Combo Pack Cold And 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.

Other

DayTime Cold & Flu

NIGHTTIME COLD & FLU RELIEF

Distributed By:

Active Ingredients (In Each 15 Ml)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant

Pain reliever/Fever reducer
Cough suppressant
Antihistamine

Uses

•temporarily relieves common cold/flu symptoms:
•nasal congestion
•cough due to minor throat & bronchial irritation
•minor aches & pains
•headache
•fever
•sore throat

temporarily relieves common cold/flu symptoms:

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

Liver Warning

This product contains acetaminophen.

Severe liver damage may occur if you take

•adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
•child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
•taken with other drugs containing acetaminophen
•adult has 3 or more alcoholic drinks every day while using this product

This product contains acetaminophen.

Severe liver damage may occur if you take

•more than 4 doses in 24 hours, which is the maximum daily amount for this product
•taken 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

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.

•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.

Ask A Doctor Before Use If You Have

•Liver disease
•Heart disease
•High blood pressure
•Thyroid disease
•Diabetes
•Trouble urinating due to enlarged prostate gland
•Cough that occurs with too much phlegm (mucus)
•Persistent or chronic cough such as occurs with smoking, asthma, or emphysema
•A sodium-restricted diet

•Liver disease
•glaucoma
•Trouble urinating due to enlarged prostate gland
•Cough that occurs with too much phlegm (mucus)
•A breathing problem or chronic cough such as occurs with smoking, asthma, or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product, do not use more than directed.

Stop Use And Ask A Doctor If

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

•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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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

•take only as directed
•Only use the dose cup provided
•do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 4 hours
Children 6 to under 12 yrs	15 mL every 4 hours
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

•take only as directed
•Only use the dose cup provided
•do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 4 hours
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other Information

each 15 mL contains:

•sodium 42 mg
•store at room temperature
•Do not refrigerate.

•each 30 mL contains: sodium 16 mg
•Store at room temperature
•Do not refrigerate

Inactive Ingredients

Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No.3, FD&C Yellow no 6, flavor, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions?

1-866-467-2748

Active Ingredients (In Each 30 Ml)

Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

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

When Using This Product

•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 & tranquilizers may increase drowsiness

Principal Display Panel - Kit Carton

Compare to the active ingredients in Vicks®DayQuil™ Cold & Flu*

NDC# 51316-618-12

DayTime

Cold & Flu

Relief

Acetaminophen, Dextromethorphan HBr,

Phenylephrine HCl

•Headache, Fever, Sore Throat, Minor Aches & Pains
•Nasal Congestion & Sinus Pressure
•Cough

Compare to the active ingredients in Vicks®NyQuil™ Cold & Flu*

NightTime