Nitecin Night-time Relief

Nitecin Night-time Relief
SPL v4
SPL
SPL Set ID dfb56532-6f72-1e4d-e053-2a95a90a1c05
Route
ORAL
Published
Effective Date 2022-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AP02 Shape: oval Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-23

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever
  • Runny nose & sneezing
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 55105-1
Active ingredients (in each Softgels) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Directions
  • Take only as directed
  • Do not exceed 4 doses per 24 hrs
Adults & children 12 yrs & over 2 softgels with water every 6 hrs
Children 4 to under 12 yrs Ask a doctor
Children under 4 yrs 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.
Questions?

Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST

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

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 daily while using this product
Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Other Information
  • Store at room temperature
Sore Throat Warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Inactive Ingredients

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

Principal Display Panel

NDC 69729-054-10

Cough & Flu/ Tos y Gripe

Nitecin

Night-ttmeRelief

Multi-Symptom Relief

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

  • Headache/ Dolor de cabeza
  • Fever/ Fiebre
  • Sore Throat/ Dolor de Garganta
  • Sneezing/ Estornudos
  • Runny Nose/ Secreción Nasal
  • Cough/ Tos

10 Softgels/ 10 Cápsulas Blandas de Gel

When Using This Product
  • 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
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.

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
Ask 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/flu symptoms:

  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever
  • Runny nose & sneezing
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)
Active ingredients (in each Softgels) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Directions
  • Take only as directed
  • Do not exceed 4 doses per 24 hrs
Adults & children 12 yrs & over 2 softgels with water every 6 hrs
Children 4 to under 12 yrs Ask a doctor
Children under 4 yrs 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.
Questions?

Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST

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

Liver Warning (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 daily while using this product
Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • Store at room temperature
Sore Throat Warning (Sore throat warning)

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 69729-054-10

Cough & Flu/ Tos y Gripe

Nitecin

Night-ttmeRelief

Multi-Symptom Relief

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

  • Headache/ Dolor de cabeza
  • Fever/ Fiebre
  • Sore Throat/ Dolor de Garganta
  • Sneezing/ Estornudos
  • Runny Nose/ Secreción Nasal
  • Cough/ Tos

10 Softgels/ 10 Cápsulas Blandas de Gel

When Using This Product (When using this product)
  • 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
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.

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
Ask Doctor Or Pharmacist Before Use If You Are (Ask 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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