418-nighttime cold and flu relief

418-nighttime cold and flu relief
SPL v5
SPL
SPL Set ID b97126d7-847d-483e-b3d1-e2b61ab1743f
Route
oral
Published
Effective Date 2020-11-11
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 glycerin polyethylene glycol, unspecified water sorbitol solution

Identifiers & Packaging

Pill Appearance
Imprint: PC10 Shape: capsule Color: green Size: 20 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-11-11

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Description

Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg


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 every day while using this product

Allergy alert: Acetaminophen may cause sever 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.

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions
  • take only as directed
  • do not exceed 4 doses per 24 hours
  • Adults and children 12 years and over: 2 softgels with water every 6 hours
  • Children 4 to under 12 years of age: ask a doctor
  • Children under 4 years of age: do not use

Other Information

Do not use if blister unit is torn or open

Inactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

May contain: sorbitol 70% solution, titanium dioxide, white edible ink



Description

Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg

Principal Display Panel

Nighttime Cold and Flu Relief


Use(s)

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

Storage
  • store at room temperature 20-25 °C (68-77° F)

Questions

Call 1-888-952-0050 Monday through Friday

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 drugs. 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

Active Ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

Pregnancy/breastfeeding

ask a health professional before use.

When Using This Product
  • 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



Ask A Doctor Before Use If
  • 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
Stop Use and Ask A Doctor If
  • pain 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.

Keep Out of Reach of Children

In case of overdose,

get medical help or contact a Poison Control Center (1-800-222-1222) 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 Or Pharmacist Before Use If
  • 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 every day while using this product

Allergy alert: Acetaminophen may cause sever 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.

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions
  • take only as directed
  • do not exceed 4 doses per 24 hours
  • Adults and children 12 years and over: 2 softgels with water every 6 hours
  • Children 4 to under 12 years of age: ask a doctor
  • Children under 4 years of age: do not use

Other Information (Other information)

Do not use if blister unit is torn or open

Inactive Ingredients (Inactive ingredients)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

May contain: sorbitol 70% solution, titanium dioxide, white edible ink



Principal Display Panel

Nighttime Cold and Flu Relief


Use(s)

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

Storage
  • store at room temperature 20-25 °C (68-77° F)

Questions

Call 1-888-952-0050 Monday through Friday

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 drugs. 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

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

When Using This Product (When using this product)
  • 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



Ask A Doctor Before Use If (Ask a doctor before use if)
  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain 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.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose,

get medical help or contact a Poison Control Center (1-800-222-1222) 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 Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • taking sedatives or tranquilizers 
  • taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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