Amazon Daytime Cold & Flu Nighttime Cold & Flu Drug Facts

Amazon Daytime Cold & Flu Nighttime Cold & Flu Drug Facts
SPL v3
SPL
SPL Set ID ceb342da-ff6d-4c19-9f78-0033d028075e
Route
ORAL
Published
Effective Date 2021-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg) Phenylephrine (10 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sorbitol Sorbitan Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: L994 Shape: oval Color: green Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-26

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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
  • store at 20-25°C (68-77°F)
Questions Or Comments?

1-800-719-9260

Uses – Daytime Cold & Flu

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • nasal congestion
  • fever
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 children even if you do not notice any signs or symptoms.

Uses – Nighttime Cold & Flu

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • runny nose and sneezing
  • fever
If Pregnant Or Breast Feeding,

ask a health professional before use.

Purpose – Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose – Nighttime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions – Daytime Cold & Flu
  • take only as directed – see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Directions – Nighttime Cold & Flu
  • take only as directed – see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Package/label Principal Display Panel

Multi-Symptom Relief

Compare to Vicks® DayQuil® Cold & Flu active ingredients

Non-Drowsy

Daytime Cold & Flu

Acetaminophen

Dextromethorphan HBr

Phenylephrine HCl

Pain Reliever/Fever Reducer

Nasal Decongestant

Cough Suppressant

Alcohol Free

Antihistamine Free

actual size

32 SOFTGELS

Multi-Symptom Relief

Compare to Vicks® NyQuil® Cold & Flu active ingredients

Nighttime Cold & Flu

Acetaminophen

Dextromethorphan HBr

Doxylamine Succinate

Pain Reliever/Fever Reducer

Antihistamine

Cough Suppressant

Alcohol Free

actual size

16 SOFTGELS

Inactive Ingredients – Daytime Cold & Flu

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive Ingredients – Nighttime Cold & Flu

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

When Using the Product – Daytime Cold & Flu

do not use more than directed

When Using This Product – Nighttime Cold & Flu
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If – Daytime Cold & Flu
  • 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.
Stop Use and Ask A Doctor If – Nighttime Cold & Flu
  • pain 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.
Ask A Doctor Before Use If You Have – Daytime Cold & Flu
  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
Active Ingredients (in Each Softgel) – Daytime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have – Nighttime Cold & Flu
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • trouble urinating due to an enlarged prostate gland
Active Ingredients (in Each Softgel) – Nighttime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Or Pharmacist Before Use If You Are – Daytime Cold & Flu

taking the blood thinning drug warfarin

Ask A Doctor Or Pharmacist Before Use If You Are – Nighttime Cold & Flu
  • taking sedatives or tranquilizers
  • 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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)
  • store at 20-25°C (68-77°F)
Questions Or Comments? (Questions or comments?)

1-800-719-9260

Uses – Daytime Cold & Flu

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • nasal congestion
  • fever
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 children even if you do not notice any signs or symptoms.

Uses – Nighttime Cold & Flu

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • runny nose and sneezing
  • fever
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Purpose – Daytime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose – Nighttime Cold & Flu

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions – Daytime Cold & Flu
  • take only as directed – see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Directions – Nighttime Cold & Flu
  • take only as directed – see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

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

Multi-Symptom Relief

Compare to Vicks® DayQuil® Cold & Flu active ingredients

Non-Drowsy

Daytime Cold & Flu

Acetaminophen

Dextromethorphan HBr

Phenylephrine HCl

Pain Reliever/Fever Reducer

Nasal Decongestant

Cough Suppressant

Alcohol Free

Antihistamine Free

actual size

32 SOFTGELS

Multi-Symptom Relief

Compare to Vicks® NyQuil® Cold & Flu active ingredients

Nighttime Cold & Flu

Acetaminophen

Dextromethorphan HBr

Doxylamine Succinate

Pain Reliever/Fever Reducer

Antihistamine

Cough Suppressant

Alcohol Free

actual size

16 SOFTGELS

Inactive Ingredients – Daytime Cold & Flu (Inactive ingredients – Daytime Cold & Flu)

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive Ingredients – Nighttime Cold & Flu (Inactive ingredients – Nighttime Cold & Flu)

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

When Using the Product – Daytime Cold & Flu (When using the product – Daytime Cold & Flu)

do not use more than directed

When Using This Product – Nighttime Cold & Flu (When using this product – Nighttime Cold & Flu)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If – Daytime Cold & Flu (Stop use and ask a doctor if – Daytime Cold & Flu)
  • 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.
Stop Use and Ask A Doctor If – Nighttime Cold & Flu (Stop use and ask a doctor if – Nighttime Cold & Flu)
  • pain 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.
Ask A Doctor Before Use If You Have – Daytime Cold & Flu (Ask a doctor before use if you have – Daytime Cold & Flu)
  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
Active Ingredients (in Each Softgel) – Daytime Cold & Flu (Active ingredients (in each softgel) – Daytime Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have – Nighttime Cold & Flu (Ask a doctor before use if you have – Nighttime Cold & Flu)
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • trouble urinating due to an enlarged prostate gland
Active Ingredients (in Each Softgel) – Nighttime Cold & Flu (Active ingredients (in each softgel) – Nighttime Cold & Flu)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Or Pharmacist Before Use If You Are – Daytime Cold & Flu (Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu)

taking the blood thinning drug warfarin

Ask A Doctor Or Pharmacist Before Use If You Are – Nighttime Cold & Flu (Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)