wal-mart daytime severe + vapor ice™

wal-mart daytime severe + vapor ice™
SPL v2
SPL
SPL Set ID 08e74a8d-8e8d-4cda-9adc-ea2ff4068353
Route
oral
Published
Effective Date 2020-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) guaifenesin (200 mg) phenylephrine (5 mg) doxylamine (6.25 mg)
Inactive Ingredients
croscarmellose sodium crospovidone (120 .mu.m) fd&c yellow no. 6 maltodextrin microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified propylene glycol silicon dioxide stearic acid sucralose talc titanium dioxide d&c yellow no. 10 fd&c blue no. 1 fd&c blue no. 2 magnesium stearate

Identifiers & Packaging

Pill Appearance
Imprint: L72V Shape: oval Color: orange Color: green Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-07-14

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg


Medication Information

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.

Uses

temporarily relieves common cold/flu symptoms:

  • fever
  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • headache
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive promotes nasal and/or sinus drainage
  • promotes nasal and/or sinus drainage
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • take only as directed - see overdose warning
  • do not exceed 8 caplets per 24 hrs

adults & children 12 yrs & over

2 caplets with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other Information
  • each caplet contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Do Not Use
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Questions Or Comments?

1-888-287-1915

When Using This Product

do not use more than directed

Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have
  • thyroid disease
  • diabetes
  • liver disease
  • heart disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Package/label Principal Display Panel

Compare to Vicks® DayQuil® Severe+ VapoCOOL active ingredients

DAYTIME SEVERE+

NON-DROWSY

VAPOR ICE

Cold & Flu

Acetaminophen – Pain Reliever/Fever Reducer

Phenylephrine HCl – Nasal Decongestant

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Relief of:

Minor aches & pains, fever

Nasal congestion & sinus pressure

Cough

Chest congestion

Alcohol-Free and Antihistamine-Free

Actual Size

16 CAPLETS

Compare to Vicks® NyQuil® Severe+ VapoCOOL active ingredients

NIGHTTIME SEVERE+

VAPOR ICE-0

Cold & Flu

Acetaminophen – Pain Reliever/Fever Reducer

Phenylephrine HCl – Nasal Decongestant

Doxylamine Succinate – Antihistamine

Dextromethorphan HBr – Cough Suppressant

Relief of:

Minor aches & pains, fever

Nasal congestion & sinus pressure

Sneezing, runny nose

Cough

Alcohol-Free

Actual Size

8 CAPLETS

Active Ingredients (in Each Caplet) Daytime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) Nighttime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

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.

Uses

temporarily relieves common cold/flu symptoms:

  • fever
  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and bronchial irritation
  • headache
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive promotes nasal and/or sinus drainage
  • promotes nasal and/or sinus drainage
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • take only as directed - see overdose warning
  • do not exceed 8 caplets per 24 hrs

adults & children 12 yrs & over

2 caplets with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other Information (Other information)
  • each caplet contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Do Not Use (Do not use)
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with 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 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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • thyroid disease
  • diabetes
  • liver disease
  • heart disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to Vicks® DayQuil® Severe+ VapoCOOL active ingredients

DAYTIME SEVERE+

NON-DROWSY

VAPOR ICE

Cold & Flu

Acetaminophen – Pain Reliever/Fever Reducer

Phenylephrine HCl – Nasal Decongestant

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Relief of:

Minor aches & pains, fever

Nasal congestion & sinus pressure

Cough

Chest congestion

Alcohol-Free and Antihistamine-Free

Actual Size

16 CAPLETS

Compare to Vicks® NyQuil® Severe+ VapoCOOL active ingredients

NIGHTTIME SEVERE+

VAPOR ICE-0

Cold & Flu

Acetaminophen – Pain Reliever/Fever Reducer

Phenylephrine HCl – Nasal Decongestant

Doxylamine Succinate – Antihistamine

Dextromethorphan HBr – Cough Suppressant

Relief of:

Minor aches & pains, fever

Nasal congestion & sinus pressure

Sneezing, runny nose

Cough

Alcohol-Free

Actual Size

8 CAPLETS

Active Ingredients (in Each Caplet) Daytime (Active ingredients (in each caplet) Daytime)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) Nighttime (Active ingredients (in each caplet) Nighttime)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

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


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