Gericare-guaiasorbdm 736

Gericare-guaiasorbdm 736
SPL v1
SPL
SPL Set ID 46a480c7-7092-b809-e063-6294a90a60cd
Route
ORAL
Published
Effective Date 2025-12-23
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 Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-01

Description

Active ingredients (per 5 mL teaspoonful) Dextromethorphan HBr 10 mg Guaifenesin 100 mg


Medication Information

Warnings and Precautions

Warnings

Do not use if you are now taking 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. 

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 throat and bronchial irritation
  • helps loosen phlegm mucus
  • helps thin bronchial secretions to make coughs more productive
Dosage and Administration

Directions 

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

Description

Active ingredients (per 5 mL teaspoonful) 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 right away.

Section 51727-6

Inactive ingreadients artificial and natural cherry flavor, citric acid, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

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 ingredients (per 5 mL teaspoonful)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

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

Directions 

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

Warnings and Precautions (34071-1)

Warnings

Do not use if you are now taking 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. 

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 right away.

Section 51727-6 (51727-6)

Inactive ingreadients artificial and natural cherry flavor, citric acid, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

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)

Purpose

  • cough suppressant
  • expectorant
Section 55106-9 (55106-9)

Active ingredients (per 5 mL teaspoonful)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg


Advanced Ingredient Data


Raw Label Data

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