Dextromethorphan Hbr 15 Mg

Dextromethorphan Hbr 15 Mg
SPL v2
SPL
SPL Set ID e2175017-6a0d-0155-e053-2995a90a65d6
Route
ORAL
Published
Effective Date 2022-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Water Fd&c Red No. 40 Polyethylene Glycol 400 Povidone Gelatin Propylene Glycol Fd&c Blue No. 1 Glycerin Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC6 Shape: oval Color: red Size: 10 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Dextromethorphan HBr, USP 15 mg


Medication Information

Warnings and Precautions

Do not use 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.

Dosage and Administration

do not take more than 8 capsules in any 24-hour period

this adult product is not intended for use in children under 12 years of age

adults and children 12 years of age and over

take 2 capsules every 6 to 8 hours, as needed

children under 12 years of age

do not use

Description

Dextromethorphan HBr, USP 15 mg

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50568-5

a cough that occurs with too much phlegm (mucus)

a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Section 51727-6

FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Section 51945-4

Section 53414-9

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

Section 55105-1

Cough suppressant

Section 55106-9

Dextromethorphan HBr, USP 15 mg

Section 60561-8

store at 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

protect from light


Structured Label Content

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Dosage and Administration (34068-7)

do not take more than 8 capsules in any 24-hour period

this adult product is not intended for use in children under 12 years of age

adults and children 12 years of age and over

take 2 capsules every 6 to 8 hours, as needed

children under 12 years of age

do not use

Warnings and Precautions (34071-1)

Do not use 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 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50568-5 (50568-5)

a cough that occurs with too much phlegm (mucus)

a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Section 51727-6 (51727-6)

FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Cough suppressant

Section 55106-9 (55106-9)

Dextromethorphan HBr, USP 15 mg

Section 60561-8 (60561-8)

store at 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

protect from light


Advanced Ingredient Data


Raw Label Data

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