FDA Label for Multi Symptom Severe Cold And Nighttime Severe Cold And Cough

View Indications, Usage & Precautions

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

Multi Symptom Severe Cold And Nighttime Severe Cold And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy,inc.. 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 Packet) – Multi Symptom Severe Cold

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Active Ingredients (In Each Packet) - Nighttime Severe Cold And Cough

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purpose - Multi Symptom Severe Cold

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Purpose - Nighttime Severe Cold And Cough

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses - Multi Symptom Severe Cold

•temporarily relieves these symptoms due to a cold:
•minor aches and pains
•minor sore throat pain
•headache
•nasal and sinus congestion
•cough due to minor throat and bronchial irritation
•temporarily reduces fever

Uses - Nighttime Severe Cold And Cough

•temporarily relieves these symptoms due to a cold:
•minor aches and pains
•minor sore throat pain
•headache
•nasal and sinus congestion
•runny nose
•sneezing
•itchy nose or throat
•itchy, watery eyes due to hay fever
•cough due to minor throat and bronchial irritation
•temporarily reduces fever

Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold And Cough

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

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 - Multi Symptom Severe Cold

•in a child under 4 years of age
•if you are allergic to acetaminophen
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.

Do Not Use - Nighttime Severe Cold And Cough

•in a child under 4 years of age
•if you are allergic to acetaminophen
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
•with any other product containing diphenhydramine, even one used on skin
•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.

Ask A Doctor Before Use If You Have - Multi Symptom Severe Cold

•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)
•cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask A Doctor Before Use If You Have - Nighttime Severe Cold And Cough

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

Ask A Doctor Or Pharmacist Before Use If You Are - Multi Symptom Severe Cold

taking the blood thinning drug warfarin

Ask A Doctor Or Pharmacist Before Use If You Are - Nighttime Severe Cold And Cough

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

When Using This Product - Multi Symptom Severe Cold

do not exceed recommended dosage

When Using This Product - Nighttime Severe Cold And Cough

•do not exceed recommended dosage
•avoid alcoholic drinks
•marked drowsiness may occur
•alcohol, sedatives, and tranquilizers may increase drowsiness
•be careful when driving a motor vehicle or operating machinery
•excitability may occur, especially in children

Stop Use And Ask A Doctor If – Multi Symptom Severe Cold /Nighttime Severe Cold And Cough

•nervousness, dizziness, or sleeplessness occurs
•fever gets worse or lasts more than 3 days
•redness or swelling is present
•new symptoms occur
•symptoms do not get better or worsen
•pain, cough or nasal congestion gets worse or lasts more than 7 days
•cough comes back or occurs with fever, 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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions – Multi Symptom Severe Cold

•do not use more than directed
•take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor

children under 4 years of age

do not use

Directions Nighttime Severe Cold And Cough

•do not use more than directed
•take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctor

children under 4 years of age

do not use

Other Information - Multi Symptom Severe Cold

•each packet contains: potassium 6 mg
•store at controlled room temperature 20°-25^oC (68°-77^oF). Protect from excessive heat and moisture.

Other Information - Nighttime Severe Cold And Cough

•each packet contains: potassium 6 mg
•store at controlled room temperature 20°-25^oC (68°-77^oF). Protect from excessive heat and moisture

Inactive Ingredients - Multi Symptom Severe Cold

anhydrous citric acid, caramel, flavors, maltodextrin, potassium citrate, silica ,sucralose, sucrose

Inactive Ingredients - Nighttime Severe Cold And Cough

anhydrous citric acid, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose, yellow #6

Questions Or Comments?

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Package/Label Principal Display Panel

Multi Symptom Severe Cold 6 PACKETS + NIGHTTIME 6 PACKETS = 12 PACKETS TOTAL

Compare to the active ingredients in Theraflu® Multi Symptom Severe Cold and Nighttime Severe Cold & Cough

Multi Symptom

Severe Cough & Cold

ACETAMINOPHEN - Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

PHENYLEPHRINE HCl – Nasal decongestant

Relieves:

Nasal congestion

Sore throat pain

Cough

Headache

Body ache

Fever

Green Tea & Honey Lemon Flavors

6 PACKETS

NIGHTTIME