Wal-mart Multi- Symptom Severe Cold And Nighttime Severe Cold And Cough Day & Night Value Pack

Wal-mart Multi- Symptom Severe Cold And Nighttime Severe Cold And Cough Day & Night Value Pack
SPL v8
SPL
SPL Set ID a2a7e568-bff8-4818-a31d-7c2efa1859c3
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg) Diphenhydramine (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Caramel Maltodextrin Potassium Chloride Silicon Dioxide Sucralose Sucrose Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-01

Description

Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant

Description

Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg

Questions Or Comments?

1-866-467-2748

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.

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
Purpose Multi Symptom Severe Cold

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Package/label Principal Display Panel

NDC# 49035-948-12

DAYTIME & NIGHTTIME RELIEF VALUE 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

12 TOTAL 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

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.
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
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
Purpose Nighttime Severe Cold and Cough

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

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.
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.
Other Information Multi Symptom Severe Cold
  • 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

Other Information Nighttime Severe Cold and Cough
  • each packet contains: potassium 6 mg
  • store at room temperature. Protect from excessive heat and moisture
When Using This Product Multi Symptom Severe Cold

do not exceed recommended dosage

Inactive Ingredients Nighttime Severe Cold and Cough

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

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
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
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

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
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.

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
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.

Structured Label Content

Questions Or Comments? (Questions or comments?)

1-866-467-2748

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health 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 (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.

Uses Multi Symptom Severe Cold (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
Purpose Multi Symptom Severe Cold (Purpose - Multi Symptom Severe Cold)

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC# 49035-948-12

DAYTIME & NIGHTTIME RELIEF VALUE 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

12 TOTAL 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

Do Not Use Multi Symptom Severe Cold (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.
Uses Nighttime Severe Cold and Cough (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
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
Purpose Nighttime Severe Cold and Cough (Purpose - Nighttime Severe Cold and Cough)

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

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.
Do Not Use Nighttime Severe Cold and Cough (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.
Other Information Multi Symptom Severe Cold (Other information - Multi Symptom Severe Cold)
  • each packet contains: potassium 6 mg
  • store at room temperature. Protect from excessive heat and moisture.
Inactive Ingredients Multi Symptom Severe Cold (Inactive ingredients - Multi Symptom Severe Cold)

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

Other Information Nighttime Severe Cold and Cough (Other information - Nighttime Severe Cold and Cough)
  • each packet contains: potassium 6 mg
  • store at room temperature. Protect from excessive heat and moisture
When Using This Product Multi Symptom Severe Cold (When using this product - Multi Symptom Severe Cold)

do not exceed recommended dosage

Inactive Ingredients Nighttime Severe Cold and Cough (Inactive ingredients - Nighttime Severe Cold and Cough)

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

When Using This Product Nighttime Severe Cold and Cough (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
Ask A Doctor Before Use If You Have Multi Symptom Severe Cold (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
Active Ingredients (in Each Packet) – Multi Symptom Severe Cold (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 (Active ingredients (in each packet) - Nighttime Severe Cold and Cough)

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Ask A Doctor Before Use If You Have Nighttime Severe Cold and Cough (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
Warnings – Multi Symptom Severe Cold /nighttime Severe Cold and Cough (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.

Ask A Doctor Or Pharmacist Before Use If You Are Multi Symptom Severe Cold (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 (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
Stop Use and Ask A Doctor If – Multi Symptom Severe Cold /nighttime Severe Cold and Cough (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.

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