FDA Label for Harris Teeter Daytime Nighttime

View Indications, Usage & Precautions

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

Harris Teeter Daytime Nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Harris Teeter, Llc. 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 Softgel) – Nighttime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active Ingredients (In Each Softgel) – Daytime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose – Nighttime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose – Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses – Nighttime Cold & Flu

temporarily relieves common cold/flu symptoms:

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

Uses – Daytime Cold & Flu

temporarily relieves common cold/flu symptoms:

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

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, lasts 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 these products.
•if you have ever had an allergic reaction to these products or any of their ingredients

Ask A Doctor Before Use If You Have – Nighttime Cold & Flu

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

Ask A Doctor Before Use If You Have – Daytime Cold & Flu

•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 as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are – Nighttime Cold & Flu

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

Ask A Doctor Or Pharmacist Before Use If You Are – Daytime Cold & Flu

taking the blood thinning drug warfarin

When Using This Product – Nighttime Cold & Flu

•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 The Product – Daytime Cold & Flu

do not use more than directed

Stop Use And Ask A Doctor If – Nighttime Cold & Flu

•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.

Stop Use And Ask A Doctor If – Daytime Cold & Flu

•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 Cold & Flu

•take only as directed – see overdose warning
•do not exceed 4 doses 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

Directions – Daytime Cold & Flu

•take only as directed – see overdose warning
•do not exceed 4 doses 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 20-25^°C (68-77^°F)

Inactive Ingredients – Nighttime Cold & Flu

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive Ingredients – Daytime Cold & Flu

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions Or Comments?

1-800-432-6111 or harristeeter.com

Package/Label Principal Display Panel

Convenience Pack

Compare to the active ingredients in Vicks® DayQuil® Cold & Flu LiquiCaps® and Vicks NyQuil® Cold & Flu LiquiCaps®

DayTime

Pain Reliever/Fever Reducer

Acetaminophen

Cough Suppressant

Dextromethorphan HBr

Nasal Decongestant

Phenylephrine HCl

COLD & FLU

Multi-Symptom Relief

Aches, Fever, Sore Throat

Nasal Congestion

Cough

Non-Drowsy

Alcohol Free/Antihistamine Free

See New Warnings

32 SOFTGELS

NightTime