750l_nighttime Cold & Flu Liquid - Cherry

750l_nighttime Cold & Flu Liquid - Cherry
SPL v1
SPL
SPL Set ID 1c3f6cbf-a00d-45b9-e063-6394a90a797c
Route
ORAL
Published
Effective Date 2024-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Acetaminophen (650 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Sorbitol Solution Alcohol Xanthan Gum Anhydrous Citric Acid Fd&c Red No. 40 Fd&c Blue No. 1 Sodium Benzoate Sodium Citrate Sucralose Glycerin Propylene Glycol Saccharin Sodium Water

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-30

Description

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg


Medication Information

Warnings and Precautions

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 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Indications and Usage

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
Dosage and Administration

Directions

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Description

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Section 50565-1

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.

Section 50566-9

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.

Section 50567-7

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, and tranquilizers may increase drowsiness
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Section 50569-3

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
Section 50570-1

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.
Section 51727-6

Inactive ingredients alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Section 55106-9

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Section 60561-8

Other information

  • each 30 mL contains: sodium 52 mg
  • store at no greater than 25°C and do not refrigerate

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Warnings and Precautions (34071-1)

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 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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, and tranquilizers may increase drowsiness
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Section 55106-9 (55106-9)

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Section 60561-8 (60561-8)

Other information

  • each 30 mL contains: sodium 52 mg
  • store at no greater than 25°C and do not refrigerate

Advanced Ingredient Data


Raw Label Data

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