Next Nighttime Cold & Flu - 603

Next Nighttime Cold & Flu - 603
SPL v1
SPL
SPL Set ID 978db223-a394-4a6d-9cfd-1e3c639feab2
Route
ORAL
Published
Effective Date 2017-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Blue No. 1 D&c Yellow No. 10 Gelatin Glycerin Polyethylene Glycol 400 Povidone Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-05-03

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Uses

temporarily relieves common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Warnings

Liver warning: This product cantains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists 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 Warnings)
  • do not exceed 4 doses per 24 hours
  • Adults and children 12 years and over:

    take 2 softgels with water every 6 hours
  • Children 4 to under 12 years: Ask a doctor

Children under 4 years: Do not use

  • When using Day Time ot Night Time products, carefully read each label to ensure correct dosing
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 an MAOI drug. If you do not know if ask a doctor or pharmacist before taking this product.
  • to make a child sleep
Drug Facts

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Questions?

Call 1-877-99-Genom (43666)

Weekdays from 8am to 6 pm

Other Information
  • store at room temperature 20-25°C (68-77°F)
Inactive Ingredients

FD&C Blue # 1, D&C Yellow # 10, Gelatin, Glycerin, Polyethylene glycol, Povvidone, Propylene glycol, Purified water, Sorbital sorbitan solution, Titanium dioxide.

When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and 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
  • a skin reaction occurs. 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.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. 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
  • 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
Next Cold & Flu Nighttime Product Label

NEXT

COLD & FLU

NIGHTTIME RELIEF

  • Fever
  • Sneezing
  • Sore Throat
  • Aches
  • Runny Nose
  • Cough

Acetaminophen/

Dextromethorphan HBr / Doxylamine succinate

Tamper evident: Do not use if blisters are torn or open

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in India

BX-056

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Warnings

Liver warning: This product cantains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists 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 Warnings)
  • do not exceed 4 doses per 24 hours
  • Adults and children 12 years and over:

    take 2 softgels with water every 6 hours
  • Children 4 to under 12 years: Ask a doctor

Children under 4 years: Do not use

  • When using Day Time ot Night Time products, carefully read each label to ensure correct dosing
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 an MAOI drug. If you do not know if ask a doctor or pharmacist before taking this product.
  • to make a child sleep
Drug Facts

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Questions?

Call 1-877-99-Genom (43666)

Weekdays from 8am to 6 pm

Other Information (Other information)
  • store at room temperature 20-25°C (68-77°F)
Inactive Ingredients

FD&C Blue # 1, D&C Yellow # 10, Gelatin, Glycerin, Polyethylene glycol, Povvidone, Propylene glycol, Purified water, Sorbital sorbitan solution, Titanium dioxide.

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and 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
  • a skin reaction occurs. 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.)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. 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)
  • 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
Next Cold & Flu Nighttime Product Label (NEXT COLD & FLU NIGHTTIME product label)

NEXT

COLD & FLU

NIGHTTIME RELIEF

  • Fever
  • Sneezing
  • Sore Throat
  • Aches
  • Runny Nose
  • Cough

Acetaminophen/

Dextromethorphan HBr / Doxylamine succinate

Tamper evident: Do not use if blisters are torn or open

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in India

BX-056

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

Advanced Ingredient Data


Raw Label Data

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