418 - nitetime cold and flu relief

418 - nitetime cold and flu relief
SPL v3
SPL
SPL Set ID 407dc4ae-882d-4a49-8884-ef048bb404cf
Route
oral
Published
Effective Date 2023-10-31
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 povidone propylene glycol water sorbitol solution

Identifiers & Packaging

Pill Appearance
Imprint: PC10 Shape: capsule Color: green Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-11-01

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 hrs, 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 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 for more than 2 days,

occurs with or is 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
  • store at room temperature 20-25 °C (68-77° F)
  • 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, white edible ink

Description

Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg

Principal Display Panel
Nitetime Cold and Flu
Use(s)

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation • sore throat • headache

• minor aches & pains • fever • runny nose & sneezing

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

Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

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

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 enlarged prostate gland

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 Breastfeeding,

ask a health professional before use.

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 hrs, 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 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 for more than 2 days,

occurs with or is 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)
  • store at room temperature 20-25 °C (68-77° F)
  • 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, white edible ink

Principal Display Panel
Nitetime Cold and Flu
Use(s)

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation • sore throat • headache

• minor aches & pains • fever • runny nose & sneezing

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

Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

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

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

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

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 enlarged prostate gland

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 Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

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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