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  5. Label Information: Daytime Severe Cold And Cough And Nighttime Severe Cold And Cough

FDA Label for Daytime Severe Cold And Cough And Nighttime Severe Cold And Cough

View Indications, Usage & Precautions

Table of Contents

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

Daytime Severe Cold And Cough And Nighttime Severe Cold And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Target 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 Packet) – Daytime Severe Cold And Cough



Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg


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



Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg


Purposes - Daytime Severe Cold And Cough



Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant


Purpose - Nighttime Severe Cold And Cough



Pain reliever/fever reducer

Antihistamine/cough Suppressant

Nasal Decongestant


Uses - Daytime 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
  • •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 – Daytime Severe Cold And Cough And 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

    Is 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 - Daytime 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.
  • •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 a MAOI, ask a doctor or pharmacist before taking this product.

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



  • •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 - Daytime Severe Cold And Cough



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 - Daytime Severe Cold And Cough



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 – Daytime Severe Cold And Cough /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 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 – Daytime Severe Cold And Cough



  • •do not use more than directed
  • •take every 4 hours, while symptoms persist, Do not take more than 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

Directions Nighttime Severe Cold And Cough



  • •do not use more than directed
  • •take every 4 hours, while symptoms persist, Do not take more than 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 - Daytime Severe Cold And Cough



  • •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 - Daytime Severe Cold And Cough



citric acid ,FD&C blue#1, FD&C red 40#, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose


Inactive Ingredients - Nighttime Severe Cold And Cough



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


Questions Or Comments?



1-866-467-2748


Package/Label Principal Display Panel



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

Value pack

daytime severe cold and cough

acetaminophen(pain reliever/ fever reducer)

dextromethorphan HBr ( cough suppressant)

phenylephrine HCl ( nasal decongestant)

aspartame free, sodium free

relief of nasal and sinus congestion,, cough ,body ache, sore throat pain, headache ,fever

berry flavor

infused with menthol and green tea flavors

6 PACKETS

nighttime severe cold and cough

acetaminophen –(pain reliever/ fever reducer)

diphenhydramine HCl – (antihistamine/ cough suppressant)

phenylephrine HCl – (nasal decongestant)

aspartame free, sodium free

relief of nasal congestion,, cough ,runny nose, sneezing, body ache, sore throat pain, headache ,fever

honey lemon flavor infused with chamomile & white tea flavors

6 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 Daytime Severe Cold & Cough and Theraflu Nighttime severe Cold & Cough

Distributed by: Target Corporation.

Minneapolis, MN 55403

TM &©2017 Target Brands, Inc.

Tamper Evident Inner Unit

Do not use if sealed packet is Torn or Broken

up & up daytime severe cold and cough and nighttime severe cold and cough value pack - 49516a11 e910 4ce0 be95 f9f6e78b9df5 01

up & up daytime severe cold and cough and nighttime severe cold and cough value pack - 49516a11 e910 4ce0 be95 f9f6e78b9df5 01


* Please review the disclaimer below.