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  5. Label Information: Multi Symptom Severe Cold And Nighttime Severe Cold And Cough

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

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH PACKET) – MULTI SYMPTOM SEVERE COLD
    2. ACTIVE INGREDIENTS (IN EACH PACKET) - NIGHTTIME SEVERE COLD AND COUGH
    3. PURPOSE - MULTI SYMPTOM SEVERE COLD
    4. PURPOSE - NIGHTTIME SEVERE COLD AND COUGH
    5. USES - MULTI SYMPTOM SEVERE COLD
    6. USES - NIGHTTIME SEVERE COLD AND COUGH
    7. WARNINGS – MULTI SYMPTOM SEVERE COLD /NIGHTTIME SEVERE COLD AND COUGH
    8. DO NOT USE - MULTI SYMPTOM SEVERE COLD
    9. DO NOT USE - NIGHTTIME SEVERE COLD AND COUGH
    10. ASK A DOCTOR BEFORE USE IF YOU HAVE - MULTI SYMPTOM SEVERE COLD
    11. ASK A DOCTOR BEFORE USE IF YOU HAVE - NIGHTTIME SEVERE COLD AND COUGH
    12. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE - MULTI SYMPTOM SEVERE COLD
    13. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE - NIGHTTIME SEVERE COLD AND COUGH
    14. WHEN USING THIS PRODUCT - MULTI SYMPTOM SEVERE COLD
    15. WHEN USING THIS PRODUCT - NIGHTTIME SEVERE COLD AND COUGH
    16. STOP USE AND ASK A DOCTOR IF – MULTI SYMPTOM SEVERE COLD /NIGHTTIME SEVERE COLD AND COUGH
    17. IF PREGNANT OR BREAST-FEEDING,
    18. KEEP OUT OF REACH OF CHILDREN.
    19. DIRECTIONS – MULTI SYMPTOM SEVERE COLD
    20. DIRECTIONS NIGHTTIME SEVERE COLD AND COUGH
    21. OTHER INFORMATION - MULTI SYMPTOM SEVERE COLD
    22. OTHER INFORMATION - NIGHTTIME SEVERE COLD AND COUGH
    23. INACTIVE INGREDIENTS - MULTI SYMPTOM SEVERE COLD
    24. INACTIVE INGREDIENTS - NIGHTTIME SEVERE COLD AND COUGH
    25. QUESTIONS OR COMMENTS?
    26. 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 Wal-mart Stores 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

    • 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 - Multi Symptom Severe Cold



  • •in a child under 12 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 12 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
  • •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
  • •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.



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, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctor

    • Age

    Dose

    Adults and children 12 years of age

    One packet

    Children under 12 years of age

    Do not use

    • •dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
    • •if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat

Directions Nighttime Severe Cold And Cough



  • •do not use more than directed
  • •take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor

    • Age

    Dose

    Adults and Children 12 years of age and over

    One packet

    Children under 12 years of age

    do not use

    • •dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
    • •if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Other Information - Multi Symptom Severe Cold



  • •each packet contains: potassium 6 mg
  • •store at room temperature. Protect from excessive heat and moisture.

Other Information - Nighttime Severe Cold And Cough



  • •each packet contains: potassium 6 mg
  • •store at room temperature. Protect from excessive heat and moisture

Inactive Ingredients - Multi Symptom Severe Cold



citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose


Inactive Ingredients - Nighttime Severe Cold And Cough



citric acid, F D & C yellow #6 , flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose,


Questions Or Comments?



1-866-467-2748


Package/Label Principal Display Panel



NDC# 49035-948-12

DAY & NIGHT PACK

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

MULTI- SYMPTOM

SEVERE COLD

ACETAMINOPHEN / PAIN RELIEVER/ FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

DYE FREE

ASPARTAME FREE

SODIUM FREE

Relieves

  • •Nasal congestion
  • •Sore throat pain
  • •Cough
  • •Headache
  • •Body ache
  • •Fever

    • GREEN TEA & HONEY LEMON FLAVORS

    INFUSED WITH MENTHOL AND GREEN TEA FLAVOR

    Naturally and Artificially Flavored

    •  6 MULTI-SYMPTOM PACKETS

      • NIGHTTIME SEVERE & COLD & COUGH

      ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER

      DIPHENHYDRAMINE HCl / ANTIHISTAMINE/ COUGH SUPPRESSANT

      PHENYLEPHRINE HCl / NASAL DECONGESTANT

      ASPARTAME FREE

      SODIUM FREE

      Relieves

      • •Nasal congestion
      • •Sore throat pain
      • •Cough
      • •Headache
      • •Body ache & fever
      • •Runny nose
      • •Sneezing

        • HONEY LEMON FLAVOR INFUSED WITH CHAMOMILE &WHITE TEA FLAVORS

        6 NIGHTTIME PACKETS

        TOTAL 12 PACKETS

        READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD.

        DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 –HOUR PERIOD.

        DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR.

        *These Products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Multi-Symptom Severe Cold & Theraflu® Nighttime Severe Cold & Cough.

        Distributed By:

        Wal-Mart Stores, Inc. Bentoville, AR 72716

        © Wal-Mart Stores, Inc.

        *This product is not manufactured or distributed by Novartis Consumer Health Inc., Owner of the registered trademark Gas-X®.

        TAMPER EVIDENT INNER UNIT:DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

        WALMART DAYTIME and NIGHTIME RELIEF VALUE PACK - image 01

        WALMART DAYTIME and NIGHTIME RELIEF VALUE PACK - image 01


* Please review the disclaimer below.