Wal-mart Severe Cold Multi-symptom Drug Facts

Wal-mart Severe Cold Multi-symptom Drug Facts
SPL v7
SPL
SPL Set ID ebe0dc20-f7b2-4e3c-bce8-248085153869
Route
ORAL
Published
Effective Date 2024-11-02
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
Acesulfame Potassium Anhydrous Citric Acid Aspartame Silicon Dioxide D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Sodium Citrate, Unspecified Form Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-07-18

Description

Acetaminophen 500 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 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 HBr 20 mg Phenylephrine HCl 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

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.

Directions
  • do not use more than directed (see overdose warning)
  • 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 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
  • in a child under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or 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.
Other Information
  • each packet contains: potassium 10 mg and sodium 25 mg
  • phenylketonurics: contains phenylalanine 22 mg per packet
  • store at 20-25°C (68-77°F). Protect product from heat and moisture.
Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions Or Comments?

1-888-287-1915

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
  • 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 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.

Active Ingredients (in Each Packet)

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 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
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use

if you are taking the blood thinning drug warfarin

Package/label Principal Display Panel

Compare to Theraflu® Multi-Symptom Severe Cold Active Ingredients

Daytime

Severe Cold Multi-Symptom

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

For relief of:

Nasal & sinus congestion

Cough

Body ache

Sore throat pain

Headache

Fever

Green Tea & Honey Lemon Flavors

6 PACKETS


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

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.

Directions
  • do not use more than directed (see overdose warning)
  • 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 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 (Do not use)
  • in a child under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or 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.
Other Information (Other information)
  • each packet contains: potassium 10 mg and sodium 25 mg
  • phenylketonurics: contains phenylalanine 22 mg per packet
  • store at 20-25°C (68-77°F). Protect product from heat and moisture.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions Or Comments? (Questions or comments?)

1-888-287-1915

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
  • 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 serious condition.
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.)

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.

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

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 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
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking the blood thinning drug warfarin

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

Compare to Theraflu® Multi-Symptom Severe Cold Active Ingredients

Daytime

Severe Cold Multi-Symptom

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

For relief of:

Nasal & sinus congestion

Cough

Body ache

Sore throat pain

Headache

Fever

Green Tea & Honey Lemon Flavors

6 PACKETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)