Cvs Health Multi-symptom Severe Cold Green Tea And Honey Lemon Flavors 6 Packets

Cvs Health Multi-symptom Severe Cold Green Tea And Honey Lemon Flavors 6 Packets
SPL v3
SPL
SPL Set ID 1dad0528-e99f-45b8-a072-3c6249bf2bcd
Route
ORAL
Published
Effective Date 2019-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Caramel Maltodextrin Potassium Citrate Silicon Dioxide Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-07-21

Description

Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever / fever reducer Cough Suppressant Nasal Decongestant


Medication Information

Purpose

Pain reliever / fever reducer Cough Suppressant Nasal Decongestant

Description

Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg

Uses
  • 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
Purposes

Pain reliever / fever reducer

Cough Suppressant

Nasal Decongestant

Warnings

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.

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

Age

Dose

children under 4 years of age

do not use

children 4 to under 12 years of age

do not use unless directed by a doctor

adults and children 12 years of age and over

one packet

  • 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.
Do Not Use
  • 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 a MAOI, ask a doctor or pharmacist before taking this product.
Other Information
  • each packet contains: potassium 6 mg
  • store at controlled room temperature 20°-25°C (68°-77°F). Protect from excessive heat and moisture.
Principal Display

CVS Health

Compare to the active ingredients in Theraflu® Multi-Symptom Severe Cold*

Severe

NDC 59779-877-06

Multi-Symptom

Severe 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

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

Multi-Symptom Severe Cold

CVS Health™ Multi-Symptom Severe Cold provides complete relief of your severe cold symptoms. This soothing hot liquid formula is dye free, aspartame free and sodium free and tastes great.

For nighttime relief, try CVS Health™ Nighttime Severe Cough & Cold.

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

Dye, Aspartame, & Sodium free

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2015 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-12431

CVS® Quality

Money back Guarantee

*This product is not manufactured or distributed by Novartis Consumer Health Inc., distributor of Theraflu® Multi-Symptom Severe Cold

Inactive Ingredients

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

Questions Or Comments

1-866-467-2748

When Using This Product

do not exceed recommended dosage

Stop Use and Ask A Doctor If
  • 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 care professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away at 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.

Active Ingredients (in Each Packet)

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

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)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

Uses
  • 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
Purposes

Pain reliever / fever reducer

Cough Suppressant

Nasal Decongestant

Warnings

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.

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

Age

Dose

children under 4 years of age

do not use

children 4 to under 12 years of age

do not use unless directed by a doctor

adults and children 12 years of age and over

one packet

  • 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.
Do Not Use (Do not use)
  • 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 a MAOI, ask a doctor or pharmacist before taking this product.
Other Information (Other information)
  • each packet contains: potassium 6 mg
  • store at controlled room temperature 20°-25°C (68°-77°F). Protect from excessive heat and moisture.
Principal Display

CVS Health

Compare to the active ingredients in Theraflu® Multi-Symptom Severe Cold*

Severe

NDC 59779-877-06

Multi-Symptom

Severe 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

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

Multi-Symptom Severe Cold

CVS Health™ Multi-Symptom Severe Cold provides complete relief of your severe cold symptoms. This soothing hot liquid formula is dye free, aspartame free and sodium free and tastes great.

For nighttime relief, try CVS Health™ Nighttime Severe Cough & Cold.

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

Dye, Aspartame, & Sodium free

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2015 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-12431

CVS® Quality

Money back Guarantee

*This product is not manufactured or distributed by Novartis Consumer Health Inc., distributor of Theraflu® Multi-Symptom Severe Cold

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments (Questions or Comments)

1-866-467-2748

When Using This Product (When using this product)

do not exceed recommended dosage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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, (If pregnant or breast-feeding,)

ask a health care professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away at 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.

Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Ask A Doctor Before Use If You Have (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)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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