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

Description

Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg

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

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.

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

 

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

Other Information
  • store at room temperature 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open
Questions/comments

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

Active Ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

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
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

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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.

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

 

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

Other Information (Other information)
  • store at room temperature 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open
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

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
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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