FDA Label for Up And Up Cold Flu Relief Day Night

Active Ingredients - Nighttime (In Each 30 Ml Dose Cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Active Ingredients - Daytime (In Each 15 Ml Tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose - Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses - Nighttime

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

Uses - Daytime

temporarily relieves common cold/flu symptoms:

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

Warnings - Nighttime

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Warnings - Daytime

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. 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, which is the maximum daily amount
• •taken with other drugs containing acetaminophen
• •adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use - Nighttime

• •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 sleepy
• •if you have ever had an allergic reaction to this product or any of its ingredients

Do Not Use - Daytime

• •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
• •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
• •a breathing problem such as emphysema or chronic bronchitis
• •glaucoma
• •a sodium-restricted diet

Ask A Doctor Before Use If You Have - Daytime

• •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 - 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

• •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

• •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

• •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.

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

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

adults & children 12 yrs & over	30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

• •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Directions - Daytime

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

adults & children 12 yrs & over	30 mL (2 TBSP) every 4 hrs
children 6 to under 12 yrs	15 mL (1 TBSP) every 4 hrs
children 4 to under 6 yrs	ask a doctor
children under 4 yrs	do not use

• •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other Information - Nighttime

• •each 30 mL dose cup contains: sodium 39 mg
• •store at 20-25°C (68-77°F)

Other Information - Daytime

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

Inactive Ingredients - Nighttime

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Inactive Ingredients - Daytime

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

Questions?

Call 1-800-910-6874

Principal Display Panel - Daytime

Compare to active ingredients in Vicks® DayQuil® Cold & Flu

cold/flu relief

multi-symptom

day / non-drowsy

pain reliever/fever reducer, cough suppressant, nasal decongestant

acetaminophen – aches/fever

dextromethorphan HBr – cough

phenylephrine HCl – nasal congestion

alcohol free, antihistamine free

DAY

original flavor

Principal Display Panel - Nighttime

Compare to active ingredients in Vicks® NyQuil® Cold & Flu

cold/flu relief

multi-symptom

night

antihistamine, cough suppressant, fever reducer/pain reliever

acetaminophen – aches/fever/sore throat

dextromethorphan HBr – cough

doxylamine succinate – sneezing, runny nose

does not contain pseudoephedrine

ALCOHOL 10%

NIGHT

cherry flavor

TWO – 12 FL OZ (355 mL), TOTAL 24 FL OZ (1.5 pt) (710 mL)

Up and Up Cold/Flu Relief Day Night Image 1 - image 01