FDA Label for Daytime Nitetime Severe

View Indications, Usage & Precautions

ACTIVE INGREDIENTS (IN EACH CAPLET) - NIGHTTIME
ACTIVE INGREDIENTS (IN EACH CAPLET) - DAYTIME
PURPOSE - NIGHTTIME
PURPOSE - DAYTIME
USES - NIGHTTIME
USES - DAYTIME
WARNINGS
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE - NIGHTTIME
ASK A DOCTOR BEFORE USE IF YOU HAVE - DAYTIME
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE - NIGHTTIME
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE - DAYTIME
WHEN USING THIS PRODUCT - NIGHTTIME
WHEN USING THIS PRODUCT - DAYTIME
STOP USE AND ASK A DOCTOR IF - NIGHTTIME
STOP USE AND ASK A DOCTOR IF - DAYTIME
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS – NIGHTTIME AND DAYTIME
OTHER INFORMATION - NIGHTTIME
OTHER INFORMATION - DAYTIME
INACTIVE INGREDIENTS - NIGHTTIME
INACTIVE INGREDIENTS - DAYTIME
QUESTIONS OR COMMENTS?
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - DAYTIME

Daytime Nitetime Severe 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.

Active Ingredients (In Each Caplet) - Nighttime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Active Ingredients (In Each Caplet) - Daytime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Purpose - Daytime

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses - Nighttime

•temporarily relieves common cold/flu symptoms:
•nasal congestion
•sinus congestion and pressure
•cough due to minor throat and bronchial irritation
•cough to help you sleep
•minor aches and pains
•headache
•fever
•sore throat
•runny nose and sneezing
•reduces swelling of nasal passages
•temporarily restores freer breathing through the nose
•promotes nasal and/or sinus drainage

Uses - Daytime

•temporarily relieves common cold/flu symptoms:
•nasal congestion
•sinus congestion and pressure
•cough due to minor throat and bronchial irritation
•minor aches and pains
•headache
•fever
•sore throat
•reduces swelling of nasal passages
•temporarily restores freer breathing through the nose
•promotes nasal and/or sinus drainage
•helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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
•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

•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 - Nighttime

•liver disease
•heart disease
•high blood pressure
•thyroid disease
•diabetes
•glaucoma
•cough that occurs with too much phlegm (mucus)
•a breathing problem such as emphysema or chronic bronchitis
•persistent or chronic cough such as occurs with smoking, asthma, or emphysema
•trouble urinating due to an enlarged prostate gland

Ask A Doctor Before Use If You Have - Daytime

•liver disease
•heart disease
•high blood pressure
•thyroid disease
•diabetes
•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, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are - Nighttime

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

Ask A Doctor Or Pharmacist Before Use If You Are - Daytime

taking the blood thinning drug warfarin

When Using This Product - Nighttime

•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, and tranquilizers may increase drowsiness

When Using This Product - Daytime

do not use more than directed

Stop Use And Ask A Doctor If - Nighttime

•you get nervous, dizzy or sleepless
•pain, nasal congestion, 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.

Stop Use And Ask A Doctor If - Daytime

•you get nervous, dizzy or sleepless
•pain, nasal congestion, 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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions – Nighttime And Daytime

•take only as directed - see overdose warning
•do not exceed 4 doses per 24 hrs

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

Other Information - Nighttime

•store at 20-25^°C (68-77^°F)

Other Information - Daytime

•each caplet contains: sodium 4 mg
•store at 20-25^°C (68-77^°F)

Inactive Ingredients - Nighttime

crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive Ingredients - Daytime

croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-632-6900

Package/Label Principal Display Panel - Daytime

COMPARE TO the active ingredients of VICKS® DAYQUIL® SEVERE

See side panel

NON-Drowsy

DayTime

Severe Cold & Flu

Acetaminophen, Phenylephrine HCl,

Dextromethorphan HBr, Guaifenesin

Pain Reliever/Fever Reducer,

Nasal Decongestant,

Cough Suppressant, Expectorant

MAXIMUM STRENGTH RELIEF

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal/Sinus Congestion & Sinus Pressure

Cough

Chest Congestion

Our Pharmacists Recommend

16 DAYTIME SEVERE CAPLETS

actual size

COMPARE TO the active ingredients of VICKS® NYQUIL® SEVERE