Cosedal Drops

Cosedal Drops
SPL v6
SPL
SPL Set ID 1241d249-ea3b-4d2b-87ed-835d6a2d286a
Route
ORAL
Published
Effective Date 2021-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Glycerin Methylparaben Propylene Glycol Propylparaben Sucrose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-02-21

Description

Active ingredients Dextromethorphan HBR Guaifenesin


Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage.

  • A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to reoccur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Indications and Usage

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage and Administration

Directions

Do not exceed 6 doses in 24 hours.

 age  dose
 12 years of age and over  2 teaspoonfuls (10 mL) every 4 hours
 Children 6 to under 12 years of age  1 teaspoonful (5 mL) every 4 hours
 Children 2 to under 6 years of age  1/2 teaspoonful (2.5 mL) every 4 hours
 Children under 2 years of age  consult your doctor

Description

Active ingredients Dextromethorphan HBR Guaifenesin

Section 50565-1

Keep out of reach of children.

Section 50570-1

Do not use:

  • This product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • 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 ingredientsCitric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben, raspberry falvor, sucrose, water

Section 51945-4

Section 53413-1

Questions?call 1-800-560-5223M-F 9 AM to 4 PM Eastern.

Section 53414-9

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

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Section 55106-9

Active ingredients

Dextromethorphan HBR

Guaifenesin

Section 60561-8

Other information

Store this product between 15°-30°C (59°-86°F)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage and Administration (34068-7)

Directions

Do not exceed 6 doses in 24 hours.

 age  dose
 12 years of age and over  2 teaspoonfuls (10 mL) every 4 hours
 Children 6 to under 12 years of age  1 teaspoonful (5 mL) every 4 hours
 Children 2 to under 6 years of age  1/2 teaspoonful (2.5 mL) every 4 hours
 Children under 2 years of age  consult your doctor

Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage.

  • A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to reoccur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50570-1 (50570-1)

Do not use:

  • This product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • 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 ingredientsCitric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben, raspberry falvor, sucrose, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?call 1-800-560-5223M-F 9 AM to 4 PM Eastern.

Section 53414-9 (53414-9)

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

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients

Dextromethorphan HBR

Guaifenesin

Section 60561-8 (60561-8)

Other information

Store this product between 15°-30°C (59°-86°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)