FDA Label for Equaline Nighttime Cold And Flu Relief

View Indications, Usage & Precautions

NIGHTTIME COLD & FLUACTIVE INGREDIENTS (IN EACH 30 ML)
PURPOSE
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
DAYTIME COLD & FLUACTIVE INGREDIENTS (IN EACH 15 ML)
KEEP OUT OF REACH OF CHILDREN.
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL

Equaline Nighttime Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product United Natural Foods, Inc. Dba Unfi. 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.

Nighttime Cold & Fluactive Ingredients (In Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

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

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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

•adult takes more than 4,000 mg of acetaminophen in 24 hours
•child takes more than 5 doses in 24 hours
•taken with other drugs containing acetaminophen
•adult has 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

•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

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

•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 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

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, and tranquilizers may increase drowsiness

do not use more than directed

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 gets worse or lasts more than 5 days (children) or 7 days (adults)
•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

•take only as directed – see Overdose warning
•only use the dose cup provided
•do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL 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
•only use the dose cup provided
•do not exceed 4 doses per 24 hrs

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

Other Information

•each 30 mL contains: sodium 38 mg
•store at 20-25^°C (68-77^°F)

•each 15 mL contains: sodium 7 mg
•store at 20-25^°C (68-77^°F)

Inactive Ingredients

alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Daytime Cold & Fluactive Ingredients (In Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Keep Out Of Reach Of Children.

Questions Or Comments?

1-877-932-7948

Principal Display Panel

compare to Vicks® NyQuil® and Vicks® DayQuil® active ingredients

combination pack

daytime

cold & flu relief

acetaminophen (pain reliever/fever reducer)

dextromethorphan HBr (cough suppressant)

phenylephrine HCl (nasal decongestant)

powerful non-drowsy relief

multi-symptom

relieves:

aches, fever & sore throat

nasal congestion

coughs

SEE NEW WARNINGS

original flavor

ALCOHOL FREE/ANTIHISTAMINE FREE

nighttime