Rugby- Chest Cong Dm 1313

Rugby- Chest Cong Dm 1313
SPL v5
SPL
SPL Set ID 60c9e493-f58c-45d6-bade-c95297512403
Route
ORAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Active ingredient Dextromethorphan HBr, 10 mg Guaifenesin 100 mg


Medication Information

Warnings and Precautions

Warnings

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, 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. 

Do not use ifyou have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking asthma, chronic bronchitis or emphysema.

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

Indications and Usage

Uses

  • temporarily relieves cough due to minor thoat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
Dosage and Administration

Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take moer than 6 doses in 24 hours
  • do not exceed recommended dose
 Adults and children 12 years and over  2 teasponsfuls (10 mL)
 Children under 12 years  do not use

Description

Active ingredient Dextromethorphan HBr, 10 mg Guaifenesin 100 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

Section 51727-6

Inactive ingredients: Cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, water, sodium citrate, sucralose, sucrose.

Section 51945-4

13

Section 53413-1

1-800-645-2158

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant

Expectorant

Section 55106-9

Active ingredient

Dextromethorphan HBr, 10 mg

Guaifenesin 100 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves cough due to minor thoat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
Dosage and Administration (34068-7)

Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take moer than 6 doses in 24 hours
  • do not exceed recommended dose
 Adults and children 12 years and over  2 teasponsfuls (10 mL)
 Children under 12 years  do not use

Warnings and Precautions (34071-1)

Warnings

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, 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. 

Do not use ifyou have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking asthma, chronic bronchitis or emphysema.

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

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

Section 51727-6 (51727-6)

Inactive ingredients: Cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, water, sodium citrate, sucralose, sucrose.

Section 51945-4 (51945-4)

13

Section 53413-1 (53413-1)

1-800-645-2158

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredient

Dextromethorphan HBr, 10 mg

Guaifenesin 100 mg


Advanced Ingredient Data


Raw Label Data

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