FDA Label for Cold And Flu Daytime/nighttime

View Indications, Usage & Precautions

Cold And Flu Daytime/nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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

NightTime COLD & FLU

Drug Facts

DayTime COLD & FLU

Drug Facts

Otc - Purpose

Active ingredients (in each Softgel)	Purpose
Acetaminophen 325 mg	Pain reliever / Fever reducer
Dextromethorphan HBr 15 mg	Cough suppressant
Doxylamine succinate 6.25 mg	Antihistamine

Active ingredients (in each Softgel)	Purpose
Acetaminophen 325 mg	Pain reliever / Fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

temporarily relieves common cold/flu symptoms:

nasal congestion
cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pains
fever

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks daily 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.

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
to make a child sleep

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
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
trouble urinating due to enlarged prostate gland

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 as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When Using This Product

do not use more than directed
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

Stop Use And Ask A Doctor If

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.

you get nervous, dizzy or sleepless
pain, nasal congestion or cough get worse or last 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.

Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

take only as directed - see Overdose warning
do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over	2 softgels with water every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

take only as directed - see Overdose warning
do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over	2 softgels with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other Information

store at room temperature between 20-25 °C (68-77 °F)

store at room temperature between 20-25 °C (68-77 °F)

Inactive Ingredients

FD&C Blue #1, FD&C Yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments

1-800-632-6900

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.

Principal Display Panel - Kit Carton

*Compare to active ingredients in Vicks^® Dayquil™ and Vicks^® Nyquil™ Cold & Flu Liquicaps™

NDC 30142-620-48

COLD & FLU

DayTime

Multi-Symptom Relief

Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant

Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg

32
SOFTGELS