FDA Label for Day Cold And Flu Night Cold And Flu

View Indications, Usage & Precautions

Day Cold And Flu Night Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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 Liquid Gel) Day Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes Day Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Active Ingredients (In Each Liquid Gel) Night Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes Night Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

•temporarily relieves these common cold and flu symptoms:
•sinus congestion and pressure
•cough
•minor aches and pains
•headache
•nasal congestion
•sore throat
•runny nose (NIGHT only)
•sneezing (NIGHT only)
•itching of the nose or throat (NIGHT only)
•itchy, watery eyes due to hay fever (NIGHT only)
•helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
•controls cough to help you get to sleep
•temporarily reduces fever

Warnings

Liver warning: These products contain 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 these products

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 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

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

Ask A Doctor Or Pharmacist Before Use If You Are

•taking the blood thinning drug warfarin
•taking sedatives or tranquilizers (NIGHT only)

When Using These Products

•do not use more than directed
•excitability may occur, especially in children (NIGHT only)
•marked drowsiness may occur (NIGHT only)
•alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
•avoid alcoholic drinks (NIGHT only)
•be careful when driving a motor vehicle or operating machinery (NIGHT only)

Stop Use And Ask A Doctor If

•nervousness, dizziness, or sleeplessness occur
•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

•do not take more than directed (see Overdose warning)
•do not take more than 10 liquid gels in any 24-hour period
•adults and children 12 years of age and older: take 2 liquid gels every 4 hours
•children under 12 years of age: do not use

Other Information

•store at 20-25^°C (68-77^°F)

Inactive Ingredients (Day Only)

edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

*may contain this ingredient

Inactive Ingredients (Night Only)

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

COMBO PACK

Compare to the active ingredients of Mucinex^® Fast-Max^® Day Cold & Flu & Mucinex^® Fast-Max^® Night Cold & Flu

fast dissolving liquid gels

MAXIMUM STRENGTH

daytime

day cold & flu

acetaminophen

dextromethorphan HBr

guaifenesin

phenylephrine HCl

pain reliever/fever reducer

cough suppressant

expectorant

nasal decongestant

relieves aches, fever & sore throat

controls cough

relieves nasal & chest congestion

thins & loosens mucus

ACTUAL SIZE

16 LIQUI GELS (liquid filled capsules)