Non Drowsy Nighttime Cold And Flu Softgel - 48ct

Non Drowsy Nighttime Cold And Flu Softgel - 48ct
SPL v1
SPL
SPL Set ID 7e59cbf2-52b6-4405-8614-8a739cc4144b
Route
ORAL
Published
Effective Date 2021-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.5 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 787 Shape: oval Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-05-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each Softgel) Purposes
Acetaminophen 325 mg Pain reliever / Fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Directions
  • take only as directed - see Overdose warning
  • do not exceed 8 softgels 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
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.
  • to make a child sleep
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.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Other Information
  • store at room temperature between 20-25 °C (68-77 °F)
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, see a doctor promptly.

Inactive Ingredients

FD&C Blue #1, FD&C Yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments

1-800-632-6900

When Using This Product
  • do not use more than directed
  • 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, & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • 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
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Principal Display Panel 325 Mg Capsule Blister Pack Carton

NDC 30142-787-48

*Compare to active ingredients in

Vicks® Nyquil™ Cold & Flu Liquicaps™

NON-DROWSY

RELIEF

COLD & FLU

NightTime

Multi-Symptom Relief

Pain Reliever

Fever Reducer

Cough Suppressant

Antihistamine

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

48

SOFTGELS


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each Softgel) Purposes
Acetaminophen 325 mg Pain reliever / Fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Directions
  • take only as directed - see Overdose warning
  • do not exceed 8 softgels 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
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.
  • to make a child sleep
Allergy Alert (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.

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Other Information (Other information)
  • store at room temperature between 20-25 °C (68-77 °F)
Sore Throat Warning (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, see a doctor promptly.

Inactive Ingredients (Inactive ingredients)

FD&C Blue #1, FD&C Yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments (Questions or comments)

1-800-632-6900

When Using This Product (When using this product)
  • do not use more than directed
  • 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, & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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 (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Principal Display Panel 325 Mg Capsule Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 325 mg Capsule Blister Pack Carton)

NDC 30142-787-48

*Compare to active ingredients in

Vicks® Nyquil™ Cold & Flu Liquicaps™

NON-DROWSY

RELIEF

COLD & FLU

NightTime

Multi-Symptom Relief

Pain Reliever

Fever Reducer

Cough Suppressant

Antihistamine

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

48

SOFTGELS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)