Amazon Daytime Severe Cold & Flu Nighttime Severe Cold & Flu Drug Facts

Amazon Daytime Severe Cold & Flu Nighttime Severe Cold & Flu Drug Facts
SPL v3
SPL
SPL Set ID 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2
Route
ORAL
Published
Effective Date 2024-11-15
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 2021-02-04

Description

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

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

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

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
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
  • 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

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
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

Questions Or Comments?

1-800-719-9260

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

Daytime Relief

Compare to Vicks® DayQuil® Severe+ VapoCOOL

active ingredients

Non-Drowsy

Daytime Severe Cold & Flu

Acetaminophen

Phenylephrine HCl

Dextromethorphan HBr

Guaifenesin

actual size

Pain Reliever/Fever Reducer

Nasal Decongestant

Cough Suppressant

Expectorant

Max Strength

16 CAPLETS

Vapor Ice

Nighttime Relief

Compare to Vicks® NyQuil® Severe+ VapoCOOL

active ingredients

Nighttime Severe Cold & Flu

Acetaminophen

Phenylephrine HCl

Doxylamine Succinate

Dextromethorphan HBr

actual size

Pain Reliever/Fever Reducer

Nasal Decongestant

Antihistamine

Cough Suppressant

Max Strength

8 CAPLETS

Vapor Ice

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

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
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

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
  • 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

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
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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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)

Daytime Relief

Compare to Vicks® DayQuil® Severe+ VapoCOOL

active ingredients

Non-Drowsy

Daytime Severe Cold & Flu

Acetaminophen

Phenylephrine HCl

Dextromethorphan HBr

Guaifenesin

actual size

Pain Reliever/Fever Reducer

Nasal Decongestant

Cough Suppressant

Expectorant

Max Strength

16 CAPLETS

Vapor Ice

Nighttime Relief

Compare to Vicks® NyQuil® Severe+ VapoCOOL

active ingredients

Nighttime Severe Cold & Flu

Acetaminophen

Phenylephrine HCl

Doxylamine Succinate

Dextromethorphan HBr

actual size

Pain Reliever/Fever Reducer

Nasal Decongestant

Antihistamine

Cough Suppressant

Max Strength

8 CAPLETS

Vapor Ice

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)