Dextromethorphan Hbr 10 Mg

Dextromethorphan Hbr 10 Mg
SPL v1
SPL
SPL Set ID 2f8b6f5e-399c-b033-e063-6294a90ac3d1
Route
ORAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (6.25 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: round Color: purple Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

Active ingredient (in each chewable tablet) Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg


Medication Information

Warnings and Precautions

Warnings

Do not use

  • to make a child sleep
  • 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 week after stopping an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Indications and Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • controls cough to help you sleep
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itching of the nose and throat
  • sneezing
  • itchy, watery eyes
Dosage and Administration

Directions

  • take every 4 hours or as directed by a doctor
  • chew thoroughly before swallowing

adults and children 12 years of age and over - 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period

children ages 6 to 12 years - 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period

children ages 6 and under - do not use

Description

Active ingredient (in each chewable tablet) Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Section 50567-7

When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • exciteability may occur, expecially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drings
  • use caution when driving a motor vehicle or operating machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

  • a sodium-restricted diet
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Section 51727-6

Inactive ingredients: Anhydrous citric acid, corn syrup, cranberry juice concentrate, FD&C Blue #1, FD&C Red #40, glycerin, malic acid, medium chain triglycerides, natural & artificial flavors, pectin, sodium chloride, trisodium citrate (anhydrous), sucralose, sucrose, water.

Section 51945-4

Section 53413-1

Questions? 1-800-245-2898, Monday - Friday, 9AM - 4PM EST

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant

Antihistamine

Section 55106-9

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Section 60561-8

Other information

  • each chewable tablet contains: potassium 5 mg and sodium 15 mg
  • store in a cool dry place at 20° - 25°C (68° - 77°F)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • controls cough to help you sleep
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itching of the nose and throat
  • sneezing
  • itchy, watery eyes
Dosage and Administration (34068-7)

Directions

  • take every 4 hours or as directed by a doctor
  • chew thoroughly before swallowing

adults and children 12 years of age and over - 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period

children ages 6 to 12 years - 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period

children ages 6 and under - do not use

Warnings and Precautions (34071-1)

Warnings

Do not use

  • to make a child sleep
  • 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 week after stopping an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • exciteability may occur, expecially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drings
  • use caution when driving a motor vehicle or operating machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a sodium-restricted diet
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Section 51727-6 (51727-6)

Inactive ingredients: Anhydrous citric acid, corn syrup, cranberry juice concentrate, FD&C Blue #1, FD&C Red #40, glycerin, malic acid, medium chain triglycerides, natural & artificial flavors, pectin, sodium chloride, trisodium citrate (anhydrous), sucralose, sucrose, water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-245-2898, Monday - Friday, 9AM - 4PM EST

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Section 60561-8 (60561-8)

Other information

  • each chewable tablet contains: potassium 5 mg and sodium 15 mg
  • store in a cool dry place at 20° - 25°C (68° - 77°F)

Advanced Ingredient Data


Raw Label Data

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