lidl nighttime cold and flu relief

lidl nighttime cold and flu relief
SPL v2
SPL
SPL Set ID e276a463-5365-4812-899b-a3af7783a0f6
Route
oral
Published
Effective Date 2019-07-02
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
d&c yellow no. 10 fd&c blue no. 1 gelatin, unspecified glycerin polyethylene glycol, unspecified povidone, unspecified propylene glycol water sorbitol sorbitan titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RP062 Shape: oval Color: green Size: 20 mm Score: 1
Marketing Status
otc monograph final active Since 2019-04-17

Purpose

Pain reliever/fever reduce r Cough Suppressant Antihistamine

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg


Medication Information

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • 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 a 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.

Uses
  •  
    temporarily relieves common cold/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

Directions
  • take only as directed- see Overdose warning
  • do not exceed 4 doses in 24 hours

adults and children 12 years and over

2 softgels with water every 6 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

Other Information
  • store at room temperature
Inactive Ingredients

D&C yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan, titanium dioxide.

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Principal Display Panel

*Compare to the active ingredients in Vicks® NyQuil® Cold & Flu liquicaps®

NDC 71141-142-32

RELIEVES

Headache

Fever & Sore throat

Minor aches & pains

Sneezing

Runny Nose

Cough

Nighttime Cold & Flue RELIEF

Acetaminophen 325 mg Pain reliever/Fever reducer

Dextromethorphan HBr 15 mg Cough suppressant

Doxylamine succinate 6.25 mg Antihistamine

24 Softgels

For ages 12 years and overs

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Nyquil® Cold & Flu LiquiCaps®

DISTRIBUTED BY

Lidl US, LLC

3500 S. Clark Street

Arlington, VA 22202

QUESTIONS?

1-844-656-5151

www.lidl.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Do Not Use
  • with any other product 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 of pharmacist before taking this product.
  • to make a child sleep
Questions Or Comments?

1-844-656-5151

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults & 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 an enlarged prostate gland
Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • 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 doses in 24 hours, which is the maximum daily amount for this product
  • 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 a 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.

Uses
  •  
    temporarily relieves common cold/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

Directions
  • take only as directed- see Overdose warning
  • do not exceed 4 doses in 24 hours

adults and children 12 years and over

2 softgels with water every 6 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

D&C yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan, titanium dioxide.

Principal Display Panel

*Compare to the active ingredients in Vicks® NyQuil® Cold & Flu liquicaps®

NDC 71141-142-32

RELIEVES

Headache

Fever & Sore throat

Minor aches & pains

Sneezing

Runny Nose

Cough

Nighttime Cold & Flue RELIEF

Acetaminophen 325 mg Pain reliever/Fever reducer

Dextromethorphan HBr 15 mg Cough suppressant

Doxylamine succinate 6.25 mg Antihistamine

24 Softgels

For ages 12 years and overs

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Nyquil® Cold & Flu LiquiCaps®

DISTRIBUTED BY

Lidl US, LLC

3500 S. Clark Street

Arlington, VA 22202

QUESTIONS?

1-844-656-5151

www.lidl.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Do Not Use (Do not use)
  • with any other product 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 of pharmacist before taking this product.
  • to make a child sleep
Questions Or Comments? (Questions or comments?)

1-844-656-5151

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • 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.

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: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults & 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 an enlarged prostate gland
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

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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