FDA Label for Daytime Nighttime Cold And Flu Relief

Nighttime Cold & Flu Active Ingredients (In Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Daytime Cold & Flu Active Ingredients (In Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Nighttime Cold & Flu Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Daytime Cold & Flu Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Nighttime Cold & Flu 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

Daytime Cold & Flu Uses

Temporarily relieves common cold/flu symptoms:

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

Warnings

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

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• 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

Nighttime Cold & Flu 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 occurs with smoking, asthma, chronic bronchitis, or emphasema
• trouble urinating due to an enlarged prostate gland

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

• 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

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

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

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

taking the blood thinning drug warfarin

Nighttime Cold & Flu When Using This Product

• do not exceed recommended dosage
• 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

Daytime Cold & Flu When Using This Product

do not use more than directed.

Nighttime Cold & Flu 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.

Daytime Cold & Flu Stop Use And Ask A Doctor If

• 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.

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

Nighttime Cold & Flu Directions

• take only as directed
• 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

Daytime Cold & Flu Directions

take only as directed
do not exceed 4 doses per 24 hrs

Other Information

• store at room temperature

Nighttime Cold & Flu Inactive Ingredients

D&C YELLOW #10, FD&C BLUE #1, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL 70% SOLUTION, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

Daytime Cold & Flu Inactive Ingredients

FD&C RED #40, FD&C YELLOW #6, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POLYSORBATE, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE.

Questions Or Comments?

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